Reported Jan 1, 2014 · Terminated
Ziehm Vista/Vista Plus 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 Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
- Lot codes and dates
83 of 83 codes
565257045758577257925840565357145759577357965844565457155760577457985846565557165761577558055847565657175762577658095854569557185763577758105855569657205764577958145860569757215765578058165861569857225766578158235862569957235767578258285863
- Amount recalled
- 83 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.
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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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