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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80960

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

Open FDA event record

Event summary

Timeline bucket
August 06, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Medical Solutions USA, Inc

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

3 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 3

AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire body.

Z-0298-2019
Recall number
Z-0298-2019
Initiated
August 06, 2018
Classification
Class II
Status
Terminated
Quantity
11

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock. This could lead to overloading the safety rope, which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning.

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

In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock. This could lead to overloading the safety rope, which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning.

Code information

Serial Numbers 1137 1138 1525 1121 1132 1529 1074 1531 1472 1136 1119

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NM, NV, NY, OH, OK, PA, PR, SC, SD, TX, UT, VA, WI, and WY.

device · product 2 of 3

Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.

Z-0299-2019
Recall number
Z-0299-2019
Initiated
August 06, 2018
Classification
Class II
Status
Terminated
Quantity
142

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock. This could lead to overloading the safety rope, which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning.

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

In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock. This could lead to overloading the safety rope, which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning.

Code information

Serial Number 23071 22776 23623 23678 22787 23021 22848 22288 22960 23082 22501 23029 23163 23164 23518 23519 22517 23538 23097 22781 23147 22506 22634 22844 23427 23169 23529 22880 23699 22429 23640 22650 22737 22542 22176 22500 22350 22247 22347 22724 22725 22895 22833 22955 22058 23400 22847 22852 22367 22600 23650 23651 22705 22928 22609 23136 23133 23137 23556 22543 23474 22821 23517 23118 23410 22789 22208 22632 23022 23024 23132 23663 23149 22743 22851 22175 23602 23018 23019 22166 22170 22945 23476 22869 23726 23035 22431 22777 22859 22861 22824 22693 22757 22651 22171 22630 23619 22941 22957 22366 23098 22998 22427 23168 22729 23459 23625 23627 22748 23054 23063 23578 23177 22352 22353 22354 23597 22736 22618 22828 22458 22695 22644 23141 22211 23059 23079 23078 23167 23464 22184 22804 22392 22234 22235 22289 22795 23172 23173 22592 22271 22914

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NM, NV, NY, OH, OK, PA, PR, SC, SD, TX, UT, VA, WI, and WY.

device · product 3 of 3

Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.

Z-0300-2019
Recall number
Z-0300-2019
Initiated
August 06, 2018
Classification
Class II
Status
Terminated
Quantity
31

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock. This could lead to overloading the safety rope, which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning.

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

In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock. This could lead to overloading the safety rope, which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning.

Code information

Serial Numbers 24077 24221 24256 24237 24263 24327 24297 24283 24288 24289 24172 24174 24186 24129 24277 24142 24304 24109 24176 24049 24058 24039 24234 24323 24105 24295 24121 24230 24276 24194 24281

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NM, NV, NY, OH, OK, PA, PR, SC, SD, TX, UT, VA, WI, and WY.