Reported Dec 23, 2015 · Terminated
GE Healthcare Optima CL323i 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 CL323i 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
- Mfg Lot or Serial # System ID
216 of 216 codes
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
- Mfg Lot or Serial # System ID
- Amount recalled
- 108
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.