Fluoroscopic X-Ray System Hand Switch May Cause Unintended Radiation
Orthoscan Inc. is recalling 22 Ziehm Vision FD fluoroscopic x-ray systems. The hand switch may fail when dropped or impacted, potentially initiating unintended radiation exposure.
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: FDA Class II medical device with a risk-of-harm hazard: mechanical failure of the hand switch from stress exposure could potentially initiate unintended radiation, creating risk to patients and operators. No injuries or incidents have been reported.
Plain-English summary
Orthoscan, Inc. is recalling 22 Ziehm Vision FD interventional fluoroscopic x-ray systems distributed throughout the United States and Puerto Rico. The recalled devices are identified by UDI EZIEZIEHMVISIONFD1651 and 22 specific serial numbers provided in the recall notice.
The wired hand switch on these devices may fail when exposed to mechanical stress such as drops or impacts. If the switching element is damaged, the hand switch may not function properly and could potentially cause the x-ray system to emit unintended radiation.
Medical facilities using these systems should verify whether they have any of the affected devices by checking the serial numbers listed in the official recall notice.
The recalled product
- Product
- Ziehm Vision FD. Interventional fluoroscopic x-ray system
- Manufacturer
- Orthoscan, Inc.
- Hazard
- unintended-radiation
- hand-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 (12)
- UDI: EZIEZIEHMVISIONFD1651 Serial Numbers: 93412
- 93443
- 93451
- 93452
- 93461
- 93483
- 93485
- 93486
- 93503
- 93619
- 93620
- 93621. 93622 93623 93628 93629 93660 93661 93662 93626 93625 93627
Distribution
Distribution scope not specified by the agency.
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