Reported Dec 24, 2014 · Terminated
Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational…
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 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
- Lot codes and dates
- Mfg Lot or Serial # System ID
00000642076BU4303695IR100000642193BU7000404046200000646910BU0314768SM1000000647792BU1904UFHNSP00000646492BU9XV386041GE800000646048BU9S416009900000644611BU6H2009VAS4400000646493BU7H0008VAS0600000645027BU4XV106184CX500000646491BU14184240
- Mfg Lot or Serial # System ID
- Amount recalled
- 10 (4 US, 6 OUS).
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
Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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