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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82514

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

Open FDA event record

Event summary

Timeline bucket
March 15, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
GE Healthcare, LLC

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

Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

Z-1199-2019
Recall number
Z-1199-2019
Initiated
March 15, 2019
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
1 device

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.

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

There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.

Code information

Model Number 5503558; System ID Number 0850060757; Serial Number B3-16-015

Distribution pattern

Nationwide distribution to AR, CA, CA, FL, MI, NM, NV, SC, TN, TX, VA, WA, WI. International distribution to Algeria, Belgium, China, Colombia, France, Hungary, Italy, Japan, Korea (Republic Of), Kuwait, Libya, Pakistan, Poland, Russia, Saudi Arabia, South Africa, Sudan, Turkey, Vietnam.

device · product 2 of 3

Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

Z-1200-2019
Recall number
Z-1200-2019
Initiated
March 15, 2019
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
49 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.

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

There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.

Code information

Model Number 5730860; System ID (Serial Number, UDI Number): 352333VASC3 (B3-17-006, 01008406821086381117020021B3-17-006); 727869SPECIALS (B3-18-005, 01008406821086381118020021B3-18-005); 407518BIPLANE (B3-17-005, 01008406821086381117010021B3-17-005); 305227KBP630 (B3-16-017, 01008406821086381116080021B3-16-017); 401BIPLANE1 (B3-18-001, 01008406821086381118010021B3-18-001); 941629IGS630 (B3-18-002, 01008406821086381118010021B3-18-002); 505841CATH3 (B3-17-032, 01008406821086381117120021B3-17-032); 7022553131 (B3-17-011, 01008406821086381117030021B3-17-011); 7028803131 (B3-17-023, 01008406821086381117080021B3-17-023); 615769SP3 (B3-17-013, 01008406821086381117040021B3-17-013); 214618INIGS (B3-16-029, 01008406821086381116120021B3-16-029); 281890BP (B3-17-024, 01008406821086381117090021B3-17-024); 956632IGS630 (B3-17-029, 01008406821086381117120021B3-17-029); 804320IGS630 (B3-16-016, 01008406821086381116070021B3-16-016); DZ1009VA03 (B3-17-015, 01008406821086381117070021B3-17-015); 220826RX10 (B3-17-003, 01008406821086381117010021B3-17-003); 082416040099 (B3-19-001, 01008406821086381119020021B3-19-001); 082416160088 (B3-18-023, 01008406821086381118110021B3-18-023); 082416100170 (B3-19-003, 01008406821086381119020021B3-19-003); XV8624CO (B3-18-012, 01008406821086381118050021B3-18-012); N4192956 (B3-17-009, 01008406821086381117030021B3-17-009); A5820150 (B3-16-023, 01008406821086381116100021B3-16-023); YV1920 (B3-16-020, 01008406821086381116100021B3-16-020); YV1922 (B3-17-002, 01008406821086381117010021B3-17-002); YV1921 (B3-16-027, 01008406821086381116120021B3-16-027); YV4500 (B3-16-032, 01008406821086381117010021B3-16-032); YV4501 (B3-17-027, 01008406821086381117110021B3-17-027); YV2503 (B3-16-019, 01008406821086381116090021B3-16-019); YV4503 (B3-18-003, 01008406821086381118020021B3-18-003); YV4502 (B3-17-030, 01008406821086381117120021B3-17-030); 0850060758 (B3-17-014, 01008406821086381117070021B3-17-014); 0850060755 (B3-17-001, 01008406821086381117010021B3-17-001); 0850060759 (B3-18-013, 01008406821086381118060021B3-18-013); KW1008VA01 (B3-17-019, 01008406821086381117070021B3-17-019); KW1005VA02 (B3-16-025, 01008406821086381116110021B3-16-025); KW1005VA01 (B3-16-026, 01008406821086381116110021B3-16-026); LY1067VA01 (B3-17-010, 01008406821086381117030021B3-17-010); PK1003VA01 (B3-17-018, 01008406821086381117060021B3-17-018); RU2011VA02 (B3-17-004, 01008406821086381117010021B3-17-004); RU9774VA01 (B3-16-021, 01008406821086381116100021B3-16-021); SA2513VA01 (B3-16-024, 01008406821086381116100021B3-16-024); ZA2940VA01 (B3-17-025, 01008406821086381117100021B3-17-025); SD1084VA01 (B3-18-010, 01008406821086381118050021B3-18-010); 06189VAS06 (B3-17-028, 01008406821086381117110021B3-17-028); 55001VAS02 (B3-16-031, 01008406821086381116120021B3-16-031); 5973XR0085 (B3-17-007, 01008406821086381117020021B3-17-007); 5973XR0075 (B3-16-030, 01008406821086381116120021B3-16-030); 5973XR0076 (B3-17-008, 01008406821086381117030021B3-17-008); 5973XR0094 (B3-17-012, 01008406821086381117040021B3-17-012)

Distribution pattern

Nationwide distribution to AR, CA, CA, FL, MI, NM, NV, SC, TN, TX, VA, WA, WI. International distribution to Algeria, Belgium, China, Colombia, France, Hungary, Italy, Japan, Korea (Republic Of), Kuwait, Libya, Pakistan, Poland, Russia, Saudi Arabia, South Africa, Sudan, Turkey, Vietnam.

device · product 3 of 3

Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

Z-1201-2019
Recall number
Z-1201-2019
Initiated
March 15, 2019
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
22 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.

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

There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.

Code information

Model Number 5771387; System ID (Serial Number, UDI Number): 501257IGS630 (B3-18-014, 01008406821246141118070021B3-18-014); 951486RU630 (B3-18-009, 01008406821246141118040021B3-18-009); 714993IGS630 (B3-18-004, 01008406821246141118020021B3-18-004); 906225EP1 (B3-18-015, 01008406821246141118070021B3-18-015); 906225CATH4 (B3-18-016, 01008406821246141118080021B3-18-016); 843797IGS30 (B3-18-030, 01008406821246141119010021B3-18-030); 4603984XV41 (B3-18-019, 01008406821246141118090021B3-18-019); MCARIGS630 (B3-18-008, 01008406821246141118040021B3-18-008); 509473RM1B (B3-18-028, 01008406821246141119010021B3-18-028); 414649IGS8 (B3-18-020, 01008406821246141118090021B3-18-020); HU1099VA07 (B3-18-024, 01008406821246141118110021B3-18-024); A670060221 (B3-19-002, 01008406821246141119020021B3-19-002); A5163326 (B3-18-007, 01008406821246141118030021B3-18-007); YV4504 (B3-18-018, 01008406821246141118090021B3-18-018); YV4505 (B3-18-027, 01008406821246141118120021B3-18-027); YV4507 (B3-18-022, 01008406821246141118110021B3-18-022); 0850060762 (B3-18-025, 01008406821246141118110021B3-18-025); 0850060763 (B3-18-026, 01008406821246141118120021B3-18-026); KW1155VA02 (B3-18-017, 01008406821246141118080021B3-18-017); PL1689VA01 (B3-18-021, 01008406821246141118100021B3-18-021); PL0302VA02 (B3-18-011, 01008406821246141118060021B3-18-011); 06189VAS11 (B3-18-029, 01008406821246141119010021B3-18-029)

Distribution pattern

Nationwide distribution to AR, CA, CA, FL, MI, NM, NV, SC, TN, TX, VA, WA, WI. International distribution to Algeria, Belgium, China, Colombia, France, Hungary, Italy, Japan, Korea (Republic Of), Kuwait, Libya, Pakistan, Poland, Russia, Saudi Arabia, South Africa, Sudan, Turkey, Vietnam.