Fluoroscopic X-ray System Hand Switch May Fail and Cause Unintended Radiation
The Ziehm Vision R fluoroscopic x-ray system has a hand switch that may fail under mechanical stress and cause unintended radiation. Ziehm Imaging, Inc. is recalling 5 affected units distributed in the U.S.
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: This is a Class II medical device recall involving a radiation-emitting system. The source states the hand switch 'may potentially initiate unintended radiation' but explicitly indicates no illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
The U.S. Food and Drug Administration is notifying of a Class II recall of the Ziehm Vision R fluoroscopic x-ray system manufactured by Ziehm Imaging GmbH and distributed by Ziehm Imaging, Inc. The affected devices are identified by serial numbers 10295, 10490, 10656, 10716, and 10997 with UDI EZIEZIEHMVISIONR1. Five units are affected.
The wired hand switch on these devices does not fully comply with the electrical safety standards IEC 60601-2-54 and 21 CFR 1020.32(c). The hand switch may fail when exposed to mechanical stress such as dropping or impacts. This failure can irreversibly damage the switching element inside the hand switch. When the switching element is damaged, the device may potentially initiate unintended radiation from the connected x-ray unit.
These five devices have been distributed in the United States, including Puerto Rico.
The recalled product
- Product
- Ziehm Vision R. Iterventional fluoroscopic x-ray system
- Manufacturer
- Orthoscan, Inc.
- Hazard
- unintended-radiation
- switch-failure
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 (5)
- UDI: EZIEZIEHMVISIONR1. Serial Numbers: 10295
- 10490
- 10656
- 10716
- 10997.
Distribution
Distribution scope not specified by the agency.
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