Reported Aug 31, 2016 · Terminated
Ziehm Vision RFD 3D 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 RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
- Lot codes and dates
Serial #'s 206282065720658206592066020671206722067820679206802068120682206832068420685206862068720712107132071420715207172071820722207232072420725207262077220793and 20794
- Amount recalled
- 31 devices
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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