CLASS II ONGOING Device recall · Reported 24 Apr 2019 · FDA Enforcement Report

Innova IGS 630, Interventional Fluoroscopic X-Ray System recalled

GE Healthcare is recalling Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic, distributed nationwide in the US. The recall was initiated on 15 Mar 2019 and the FDA has classified it as Class II.

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Lot, batch or date codesModel 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)

Quantity recalled49 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1200-2019
FDA event ID: 82514
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 15 Mar 2019
FDA classified: 18 Apr 2019
Reported: 24 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

15 Mar 2019	Recall initiated by company
18 Apr 2019	Classified by FDA	+34 days
24 Apr 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arkansas California Florida Michigan New Mexico Nevada South Carolina Tennessee Texas Virginia Washington Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

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)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 82514

This product is part of a recall event; the main page for the event is Innova IGS 6, Interventional Fluoroscopic X-Ray System used recalled.

Reported	Class	Recall	Company	Reason	Where
24 Apr 2019	CLASS II	Innova IGS 6, Interventional Fluoroscopic X-Ray System used recalled	GE Healthcare	Other	Nationwide
24 Apr 2019	CLASS II	Innova IGS 630, Angiographic X-Ray recalled by GE Healthcare	GE Healthcare	Other	Nationwide

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