Reported Aug 31, 2016 · Terminated
Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
Ziehm Imaging 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: Ziehm Imaging Inc · 6280 Hazeltine National Dr Ste 100 · Orlando, FL · 32822-5114
Is this the product you have?
- Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
- Lot codes and dates
- Serial # 10841.
- Amount recalled
- 1 device
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
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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