Reported Jan 1, 2014 · Terminated
Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. 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 · Orlando, FL · 32822-5114
Is this the product you have?
- Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
- Lot codes and dates
50104506945070450714508125087550105506955070550785508135090150106506965070650786508155090250107506975070750802508175092550108506985070850803508185092650109506995070950804508195092750653507005071050805508205093750663507015071150808508725093950671507025071250810508735069350703507135081150874
- Amount recalled
- 58 devices
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.
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.
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