Reported Jan 1, 2014 · Terminated

Ziehm Vision R 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 R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Lot codes and dates
  • 103 of 103 codes

    • 10016
    • 10070
    • 10135
    • 10153
    • 10235
    • 10485
    • 10026
    • 10071
    • 10092
    • 10154
    • 10260
    • 10486
    • 10028
    • 10072
    • 10093
    • 10155
    • 10265
    • 10488
    • 10030
    • 10073
    • 10094
    • 10156
    • 10266
    • 10489
    • 10031
    • 10074
    • 10109
    • 10162
    • 10396
    • 10490
    • 10038
    • 10075
    • 10111
    • 10181
    • 10431
    • 10491
    • 10042
    • 10076
    • 10117
    • 10192
    • 10434
    • 10510
    • 10045
    • 10078
    • 10118
    • 10196
    • 10435
    • 10519
    • 10046
    • 10080
    • 10119
    • 10197
    • 10436
    • 10520
    • 10048
    • 10081
    • 10121
    • 10198
    • 10443
    • 10521
Amount recalled
103 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, 5:25 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.