Reported Jul 4, 2018 · Terminated
Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures.
Siemens Medical Solutions USA, Inc.
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: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures.
- Lot codes and dates
- 105007
- Amount recalled
- 1
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
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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