The Recall Desk
HighFDA (Devices)·Z-2640-2016·Announced 2016-08-31

Ziehm Vision RFD Mot Mobile C-arm Recalled for Timer Malfunction

Ziehm Imaging is recalling 14 mobile C-arm devices because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a safety feature malfunction (radiation warning timer) that could lead to unintended exposure, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Ziehm Imaging Inc is recalling 14 units of the Ziehm Vision RFD Mot, a mobile C-arm used for mobile fluoroscopic imaging. The recall is due to a malfunction in the radiation-warning timer and the 3D-specific interval warning. When this defect occurs, the 5-minute timer dialogs and beeper will not activate until the unit is rebooted.

The affected devices were distributed in the United States, including Puerto Rico, and in the states of Florida, Georgia, Virginia, Massachusetts, Maine, Michigan, New York, New Jersey, Pennsylvania, Rhode Island, Illinois, Texas, Arizona, California, Nevada, Utah, and Washington. The specific serial numbers for the recalled units are 20379, 20398, 20399, 20403, 20413, 20415, 20534, 20601, 20602, 20618, 20619, 20620, 20621, and 20720.

Healthcare facilities should check their inventory for these serial numbers. If a device is affected, users should follow the instructions provided by Ziehm Imaging Inc to address the timer malfunction.

The recalled product

Product
Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging
Manufacturer
Ziehm Imaging Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
14

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • Serial #'s 20379
  • 20398
  • 20399
  • 20403
  • 20413
  • 20415
  • 20534
  • 20601
  • 20602
  • 20618
  • 20619
  • 20620
  • 20621
  • and 20720.

Distribution

Distributed in 18 states:

Part of a larger recall action

This product is one of 6 recalled by Ziehm Imaging Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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