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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80577

28 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 27, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems Gmbh, DMC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

28 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 28

DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082

Z-2841-2018
Recall number
Z-2841-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: 496224/SN12000042, 431530/SN09000159

Distribution pattern

US Nationwide; International to 66 countries

device · product 2 of 28

DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028

Z-2842-2018
Recall number
Z-2842-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: SN17000395, SN17000372

Distribution pattern

US Nationwide; International to 66 countries

device · product 3 of 28

DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

Z-2843-2018
Recall number
Z-2843-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: SN15000196 SN15000180 SN15000282 SN15000281 SN15000192 SN15000189

Distribution pattern

US Nationwide; International to 66 countries

device · product 4 of 28

DigitalDiagnost Release 3 (Stitching Patient Support) 712025

Z-2844-2018
Recall number
Z-2844-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: 510694/SN12000240 510890/SN12000259 511451/SN13000066 510334/SN12000218 511346/SN13000008 511214/SN12000353 12000161 510089/SN12000293

Distribution pattern

US Nationwide; International to 66 countries

device · product 5 of 28

DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026

Z-2845-2018
Recall number
Z-2845-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: SN13000495 SN14000058 SN13000463 SN14000051 SN14000214 SN14000047 SN14000077 SN13000484 SN14000082 SN14000163 SN14000133 SN14000134 SN14000134 SN14000023 SN14000041

Distribution pattern

US Nationwide; International to 66 countries

device · product 6 of 28

BuckyDiagnost Ceiling System (Stitching Patient Support) 704031

Z-2846-2018
Recall number
Z-2846-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Number: 477195/SN11000090

Distribution pattern

US Nationwide; International to 66 countries

device · product 7 of 28

CombiDiagnost R90 (Stitching Patient Support) 709030

Z-2847-2018
Recall number
Z-2847-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: SN17000130 SN17000018

Distribution pattern

US Nationwide; International to 66 countries

device · product 8 of 28

DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081

Z-2848-2018
Recall number
Z-2848-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: 428633/SN09000234 430908/SN09000165 487800/SN11000531

Distribution pattern

US Nationwide; International to 66 countries

device · product 9 of 28

DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029

Z-2849-2018
Recall number
Z-2849-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Number: SN16000395

Distribution pattern

US Nationwide; International to 66 countries

device · product 10 of 28

DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028

Z-2850-2018
Recall number
Z-2850-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: SN17000283 SN15000078 SN15000115 SN17000326 SN15000114 SN17000171 SN17000058 SN17000190 SN15000016 SN15000316 SN17000027 SN14000047 SN17000024 SN15000015 SN17000342 SN14000108

Distribution pattern

US Nationwide; International to 66 countries

device · product 11 of 28

DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027

Z-2851-2018
Recall number
Z-2851-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: SN17000294 SN17000295 SN17000114 SN17000185 SN17000362 SN17000263 SN17000264 SN17000399 SN15000017 SN17000235 SN18000001 SN17000414 SN17000376 SN16000352 SN17000311 SN17000070 SN14000079 SN14000080 SN17000044 SN17000346 SN14000052 SN17000045 SN17000351 SN17000038 SN17000262 SN17000126 SN15000122 SN17000100 SN17000422 SN17000359 SN16000390 SN15000048 SN17000084 SN16000386 SN17000106 SN17000288 SN17000278 SN17000335 SN16000394 SN16000387 SN17000151 SN17000352 SN17000329 SN17000349 SN17000303 SN17000334 SN17000216 SN17000305 SN17000398 SN15000328 SN17000289 SN17000411 SN17000436 SN17000090 SN15000006 SN17000179 SN17000034 SN17000231 SN16000355 SN17000166 SN17000127 SN16000421 SN16000398 SN14000105 SN16000430 SN16000418 SN17000150 SN17000092 SN15000054 SN15000097 SN15000110 SN17000373 SN15000132 SN14000040 SN14000045 SN15000098 SN16000435 SN15000142 SN15000151 SN17000141 SN15000410 SN15000417 SN16000402

Distribution pattern

US Nationwide; International to 66 countries

device · product 12 of 28

DigitalDiagnost 4.1 (Stitching Patient Support) 712225

Z-2852-2018
Recall number
Z-2852-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Number: SN16000137

Distribution pattern

US Nationwide; International to 66 countries

device · product 13 of 28

DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029

Z-2853-2018
Recall number
Z-2853-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Number: SN15000433

Distribution pattern

US Nationwide; International to 66 countries

device · product 14 of 28

DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028

Z-2854-2018
Recall number
Z-2854-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: SN16000197 SN15000288 SN16000234 SN16000008 SN15000304 SN15000283 SN15000174 SN15000225 SN16000124 SN16000023 550162 SN15000350 SN16000092 SN15000379 SN16000283 SN16000104 SN15000173

Distribution pattern

US Nationwide; International to 66 countries

device · product 15 of 28

DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

Z-2855-2018
Recall number
Z-2855-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: SN15000291 SN16000158 SN15000374 SN15000298 SN16000191 SN15000327 SN17000317 SN16000321 SN16000063 SN15000364 SN15000444 SN16000143 SN15000443 SN16000037 SN15000371 SN15000303 SN16000137 SN16000329 SN16000095 SN16000308 SN16000328 SN16000043 SN16000151 SN15000442 SN16000147 SN16000146 SN16000050 SN16000271 SN16000253 SN16000073 SN16000296 SN16000297 SN16000311 SN16000263 SN16000371 SN16000214 SN16000142 SN16000025 SN16000165 SN16000105 SN15000264 SN16000264 SN16000302 SN16000113 SN16000112 SN16000123 SN15000373 SN15000165 SN16000347 SN16000375 SN15000355 SN16000225

Distribution pattern

US Nationwide; International to 66 countries

device · product 16 of 28

DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081

Z-2856-2018
Recall number
Z-2856-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: 456897/SN10000166 402837/SN0802410 2010345 410774/SN0802694

Distribution pattern

US Nationwide; International to 66 countries

device · product 17 of 28

DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052

Z-2857-2018
Recall number
Z-2857-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: 422102/SN0902020 435210/SN0902204 460471/SN1002019 433651/SN0902114 427610/SN0902108 470160/SN1102003 447013/SN1002008 445778/SN1002006 420208/SN0902019

Distribution pattern

US Nationwide; International to 66 countries

device · product 18 of 28

DigitalDiagnost Dual Detector (Stitching Patient Support) 712022

Z-2858-2018
Recall number
Z-2858-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: 488713/SN11000577 488714/SN11000572 444623/SN10000136 480503/SN11000473 480504/SN11000478 410040/SN08000021 422832/SN09000061 462407/SN10000363 448130/SN10000008 464981/SN10000471 455752/SN10000200 454061/SN10000216 426292/SN09000386 455546/SN10000143 420090/SN09000018 474817/SN11000080 474238/SN11000042 461799/SN10000347 455621/SN10000163 471148/SN11000122 471147/SN11000120 482904/SN11000375 482905/SN11000373 482903/SN11000379 440249/SN09000347 481021/SN11000446 487808/SN11000526 441778/SN09000452 432989/SN09000285 478307/SN12000004 476338/SN12000026 476034/SN12000027 422536/SN09000199 486638/SN11000494 466808/SN10000464 462593/SN10000439 471150/SN10000660 478233/SN11000233 473897/SN11000165 482501/SN11000527 453200/SN10000133 456093/SN10000204 461979/SN10000701 461976/SN10000704 443093/SN09000454 445110/SN09000461 16750755 477524/SN11000434 475932/SN11000341 475866/SN11000350 451542/SN10000098 442534/SN09000423 443443/SN09000420 484558/SN11000525 479928/SN11000287 466029/SN10000420 472613/SN11000162 480061/SN11000474 453085/SN10000125 467927/SN10000713 450779/SN10000062 480881/SN11000274 476835/SN11000179 442005/SN10000298 444627/SN10000142 442310/SN10000149 478181/SN11000455 481142/SN11000318 467348/SN11000207 441637/SN09000354 441638/SN09000356 464863/SN10000533 464880/SN10000714 421977/SN09000115 449365/SN10000110 464755/SN10000391 430355/SN09000214 451543/SN10000100

Distribution pattern

US Nationwide; International to 66 countries

device · product 19 of 28

DigitalDiagnost Dual Detector (Stitching Patient Support) 712022

Z-2859-2018
Recall number
Z-2859-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: 488713/SN11000577 488714/SN11000572 444623/SN10000136 480503/SN11000473 480504/SN11000478 410040/SN08000021 422832/SN09000061 462407/SN10000363 448130/SN10000008 464981/SN10000471 455752/SN10000200 454061/SN10000216 426292/SN09000386 455546/SN10000143 420090/SN09000018 474817/SN11000080 474238/SN11000042 461799/SN10000347 455621/SN10000163 471148/SN11000122 471147/SN11000120 482904/SN11000375 482905/SN11000373 482903/SN11000379 440249/SN09000347 481021/SN11000446 487808/SN11000526 441778/SN09000452 432989/SN09000285 478307/SN12000004 476338/SN12000026 476034/SN12000027 422536/SN09000199 486638/SN11000494 466808/SN10000464 462593/SN10000439 471150/SN10000660 478233/SN11000233 473897/SN11000165 482501/SN11000527 453200/SN10000133 456093/SN10000204 461979/SN10000701 461976/SN10000704 443093/SN09000454 445110/SN09000461 16750755 477524/SN11000434 475932/SN11000341 475866/SN11000350 451542/SN10000098 442534/SN09000423 443443/SN09000420 484558/SN11000525 479928/SN11000287 466029/SN10000420 472613/SN11000162 480061/SN11000474 453085/SN10000125 467927/SN10000713 450779/SN10000062 480881/SN11000274 476835/SN11000179 442005/SN10000298 444627/SN10000142 442310/SN10000149 478181/SN11000455 481142/SN11000318 467348/SN11000207 441637/SN09000354 441638/SN09000356 464863/SN10000533 464880/SN10000714 421977/SN09000115 449365/SN10000110 464755/SN10000391 430355/SN09000214 451543/SN10000100 ***Added 5/6/21*** SN15000449

Distribution pattern

US Nationwide; International to 66 countries

device · product 20 of 28

DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084

Z-2860-2018
Recall number
Z-2860-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: SN15000153 SN17000147 SN15000211 SN17000160

Distribution pattern

US Nationwide; International to 66 countries

device · product 21 of 28

DigitalDiagnost Release 3 (Stitching Patient Support) 712025

Z-2861-2018
Recall number
Z-2861-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: SN13000132 514201/SN12000334 SN13000145 485094/SN11000028 485093/SN11000029 SN13000150 498131/SN12000072 515567/SN12000365 SN13000186 SN13000227 SN13000280 514978/SN12000374 514917/SN12000338 520248/SN13000057 512305/SN12000296 499378/SN12000065 515647/SN12000361 SN13000162 SN13000322 SN13000388 SN13000440 518940/SN13000015 498389/SN12000046 SN13000419 SN13000183 497871/SN12000116 497872/SN12000123 SN13000170 493886/SN12000067 SN13000247 521377/SN13000113 512184/SN12000267 514540/SN12000384 514291/SN12000322 506687/SN12000184 506685/SN12000185 515888/SN12000342 515889/SN12000357 519026/SN13000028 514210/SN12000313 505513/SN12000302 519509/SN13000056 492928 515713/SN13000093 SN13000426 513549/SN12000332 504226/SN12000212 513792/SN12000295 SN13000260 514303/SN12000395 494356/SN12000005 515262/SN12000324 SN13000311 SN13000111 496399/SN12000118 496394/SN12000045 497058/SN12000030 518706/SN13000045 506258/SN12000152 519609/SN13000060 512167/SN13000097 SN13000342 504404/SN12000223 519329/SN13000044 SN13000265 192929/SN11000055 SN13000447 SN13000366 SN13000456 504665/SN12000213 521255/SN13000104 491790/SN11000073 495027/SN12000034 517758/SN12000389 SN13000341 SN13000314 504769/SN12000214 488603/SN11000063 489349/SN11000067 514290/SN13000013 512235/SN12000289 SN13000176 515464/SN12000327 491708/SN12000001 497889/SN12000106 492192/SN12000028 SN13000336 SN13000143 499759/SN12000080 503540/SN12000197

Distribution pattern

US Nationwide; International to 66 countries

device · product 22 of 28

DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026

Z-2862-2018
Recall number
Z-2862-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: SN14000256 SN14000250 SN15000024 SN14000170 SN14000052 SN14000224 SN15000039 SN14000144 SN14000253 SN14000239 SN14000186 SN14000075 SN14000193 SN14000254 SN15000001 SN14000089 SN14000223 SN14000267 SN14000238 SN14000164 SN14000165 SN14000200 SN14000005 SN14000040 SN15000015 SN15000029 SN14000120

Distribution pattern

US Nationwide; International to 66 countries

device · product 23 of 28

DigitalDiagnost Single Detector (Stitching Patient Support) 712020

Z-2863-2018
Recall number
Z-2863-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: 399921/SN08000023 410038/SN08000091 402577/SN09000137 479651/SN11000391 443237/SN09000411 496881/SN12000104 489345/SN11000590 459498/SN10000231 483525/SN11000377 468302/SN10000537 485692/SN11000443 422533/SN09000072 450553/SN10000089 414087/SN08000100 472611/SN11000056 443235/SN09000450 481036/SN11000471 471070/SN10000695 471047/SN10000700 455221/SN10000251 460072/SN10000336 478109/SN11000327 475856/SN11000315 415754/SN08000063 443660/SN10000010 440700/SN10000030 440260/SN09000350 447603/SN09000468 448647/SN10000111 467487/SN11000085 467484/SN10000602 477526/SN11000311 490997/SN12000106 451267/SN10000104 445433/SN09000434 488711/SN11000615 470906/SN11000142 485620/SN12000002 448671/SN10000076 480052/SN11000286 480053/SN11000288 439920/SN09000329 412942/SN08000036 418438/SN08000110 431111/SN09000237

Distribution pattern

US Nationwide; International to 66 countries

device · product 24 of 28

DigitalDiagnost Upgrades (Stitching Patient Support) 712083

Z-2864-2018
Recall number
Z-2864-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: 437736/SN09000282 491574/SN12000099 488712 415314/SN0902058 445533/SN10000006 414930/SN08000055 SN13000238 SN13000214 504759/SN12000356 487719/SN11000538 504766/SN12000207 SN14000264 SN14000264 469223/SN10000643 493888/SN12000004 316236 306773 306776 334582 325938 SN08000301 396570/SN0802320 SN08000216

Distribution pattern

US Nationwide; International to 66 countries

device · product 25 of 28

DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052

Z-2865-2018
Recall number
Z-2865-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: 363679 404164/SN0802462 378830/SN0802004 341693 358494 359442 396571/SN0802311 359449 346075 382021/SN0802313 374374 404298/SN0802474 402570/SN0802420 373501 373500 382272/SN0802113 368428 382012/SN0702520 376667 356957 392502/SN0802179 407423/SN0802638 359767 368619 358641 357697 381998/SN0702488 413829/SN0802631 358320 400364/SN0802522 404166/SN0802441 356981 390272/SN0802364 390273/SN0802366 412482/SN0802683 348997 396576/SN0802233 372848 373508 383084/SN0802127

Distribution pattern

US Nationwide; International to 66 countries

device · product 26 of 28

DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062

Z-2866-2018
Recall number
Z-2866-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: 386786/SN0702512 375366 416255/SN0902004 358322 388667/SN0802105 375367 397229/SN0802250 396838/SN0802365 386108/SN0802044 405687/SN0802469 354125 362438 406156/SN0802537 413697/SN0802634 402853/SN0902012 405889/SN0802629 383385/SN0802011 378827/SN0802021 384013/SN0702495 358017 358496 377925/SN0802060 356953 355621 357888 356956 368431 356963 406016/SN0802476 346522 375370 70700 351321 392504/SN0802182

Distribution pattern

US Nationwide; International to 66 countries

device · product 27 of 28

EasyDiagnost Eleva DRF (Stitching Patient Support) 706032

Z-2867-2018
Recall number
Z-2867-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: 470350/SN10000103 482735/SN11000053 475222/SN11000013 486215/SN11000104 484559/SN11000063 77124552 499144/SN12000035 502428/SN12000048 505693/SN12000054

Distribution pattern

US Nationwide; International to 66 countries

device · product 28 of 28

EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050

Z-2868-2018
Recall number
Z-2868-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

Code information

Serial Numbers: SN17000027 SN16000011 SN16000014 SN16000036 SN16000015 SN15000050 476034/SN12000027 476338/SN12000026 SN17000022 SN15000029 SN16000017 SN16000009 SN13000078 SN16000048 SN16000004 SN13000029 SN14000068 511923/SN12000044 514827/SN12000098 514827/SN12000098 SN14000044 ***Updated 5/6/21*** SN15000055

Distribution pattern

US Nationwide; International to 66 countries