Reported Dec 23, 2015 · Terminated
GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from…
GE Medical Systems, 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 Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare Optima IGS 320
- Product UsageThe angiographic X-ray systems are 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. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures
- Lot codes and dates
84 of 84 codes
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
- Amount recalled
- 45
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems.
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.
Free recall alerts
Get alerted about new GE Medical Systems, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.