Reported Jan 1, 2014 · Terminated

Ziehm Vision(2) 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 Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Lot codes and dates
    • 9760
    • 9937
    • 90067
    • 90816
    • 9763
    • 9945
    • 90102
    • 90817
    • 9828
    • 9946
    • 90103
    • 90819
    • 9840
    • 9983
    • 90142
    • 90823
    • 9841
    • 9985
    • 90636
    • 90838
    • 9848
    • 9986
    • 90699
    • 90842
    • 9849
    • 90024
    • 90715
    • 90863
    • 9855
    • 90031
    • 90750
    • 90864
    • 9856
    • 90032
    • 90758
    • 90865
    • 9894
    • 90033
    • 90773
    • 90899
    • 9896
    • 90034
    • 90774
    • 90909
    • 9923
    • 90054
    • 90813
    • 90919
    • 9924
    • 90065
    • 90814
    • 9936
    • 90066
    • 90815
Amount recalled
54 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 23, 2014 · Data as of Sep 19, 6:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.