High FDA (Devices)·Z-2639-2016·Announced 2016-08-31

Ziehm Vision RFD 3D Mobile C-arm Recalled for Timer Malfunction

Ziehm Imaging Inc is recalling 31 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 where a safety warning system (radiation timer) may fail, creating a risk of harm (excessive radiation exposure) that has not yet been reported as an injury or illness, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Ziehm Imaging Inc is recalling 31 units of the Ziehm Vision RFD 3D Mobile C-arm 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 20628, 20657, 20658, 20659, 20660, 20671, 20672, 20678, 20679, 20680, 20681, 20682, 20683, 20684, 20685, 20686, 20687, 20712, 10713, 20714, 20715, 20717, 20718, 20722, 20723, 20724, 20725, 20726, 20772, 20793, and 20794.

Healthcare facilities and users should check their device serial numbers against the list provided by the manufacturer. If a device is affected, users should contact Ziehm Imaging Inc for instructions on how to resolve the issue, which may involve a reboot or other corrective action to ensure the warning systems function correctly.

The recalled product

Product: Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
Manufacturer: Ziehm Imaging Inc
Category: Medical Device — Imaging Equipment
Hazard: radiation-exposure
software-malfunction
Affected units: 31

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 (20)

Serial #'s 20628
20657
20658
20659
20660
20671
20672
20678
20679
20680
20681
20682
20683
20684
20685
20686
20687
20712
10713
20714

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 →

Same manufacturer · Ziehm Imaging Inc

See all →

Moderate
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm Recalled for Missing Label Date
FDA (Devices) · 2017-05-24
High
Ziehm Solo Mobile C-arm Recalled for Radiation Warning Timer Malfunction
FDA (Devices) · 2016-08-31
High
Ziehm Vision RFD Mot Mobile C-arm Recalled for Timer Malfunction
FDA (Devices) · 2016-08-31
High
Ziehm Vision RFD Mobile C-arm Recalled for Radiation Warning Timer Malfunction
FDA (Devices) · 2016-08-31
High
Ziehm Vision2 Mobile C-arm Recalled for Radiation Warning Timer Malfunction
FDA (Devices) · 2016-08-31

Same hazard · radiation exposure