Reported Apr 24, 2019 · Ongoing
Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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.
- Lot codes and dates
- Model Number 5730860; System ID (Serial Number
- UDI Number)
98 of 98 codes
352333VASC3 (B3-17-00601008406821086381117020021B3-17-006)727869SPECIALS (B3-18-00501008406821086381118020021B3-18-005)407518BIPLANE (B3-17-00501008406821086381117010021B3-17-005)305227KBP630 (B3-16-01701008406821086381116080021B3-16-017)401BIPLANE1 (B3-18-00101008406821086381118010021B3-18-001)941629IGS630 (B3-18-00201008406821086381118010021B3-18-002)505841CATH3 (B3-17-03201008406821086381117120021B3-17-032)7022553131 (B3-17-01101008406821086381117030021B3-17-011)7028803131 (B3-17-02301008406821086381117080021B3-17-023)615769SP3 (B3-17-01301008406821086381117040021B3-17-013)214618INIGS (B3-16-02901008406821086381116120021B3-16-029)281890BP (B3-17-02401008406821086381117090021B3-17-024)956632IGS630 (B3-17-02901008406821086381117120021B3-17-029)804320IGS630 (B3-16-01601008406821086381116070021B3-16-016)DZ1009VA03 (B3-17-01501008406821086381117070021B3-17-015)220826RX10 (B3-17-00301008406821086381117010021B3-17-003)082416040099 (B3-19-00101008406821086381119020021B3-19-001)082416160088 (B3-18-02301008406821086381118110021B3-18-023)082416100170 (B3-19-00301008406821086381119020021B3-19-003)XV8624CO (B3-18-01201008406821086381118050021B3-18-012)N4192956 (B3-17-00901008406821086381117030021B3-17-009)A5820150 (B3-16-02301008406821086381116100021B3-16-023)YV1920 (B3-16-02001008406821086381116100021B3-16-020)YV1922 (B3-17-00201008406821086381117010021B3-17-002)YV1921 (B3-16-02701008406821086381116120021B3-16-027)YV4500 (B3-16-03201008406821086381117010021B3-16-032)YV4501 (B3-17-02701008406821086381117110021B3-17-027)YV2503 (B3-16-01901008406821086381116090021B3-16-019)YV4503 (B3-18-00301008406821086381118020021B3-18-003)YV4502 (B3-17-03001008406821086381117120021B3-17-030)
- Amount recalled
- 49 devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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