Ziehm Vision RFD X-ray System Hand Switch May Cause Unintended Radiation
Orthoscan's Ziehm Vision RFD fluoroscopic x-ray systems may have wired hand switches that fail under mechanical stress, potentially causing unintended radiation. The manufacturer is recalling affected units in the U.S. and Puerto Rico.
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 an FDA Class II recall of a medical device with potential for serious harm (unintended radiation exposure). Although no illnesses or injuries have been reported, the hazard is significant, placing this in the High severity category per the rubric.
Plain-English summary
The Ziehm Vision RFD is an interventional fluoroscopic x-ray system used in medical facilities. Orthoscan, Inc. is recalling 30 units distributed throughout the U.S. and Puerto Rico.
The wired hand switch may not fully meet regulatory requirements (IEC 60601-2-54 and 21 CFR 1020.32(c)). Mechanical stress such as shocks or impacts from dropping can irreversibly damage the switching element. A defective switch may potentially cause unintended radiation from the x-ray unit.
Additional information and the list of affected serial numbers are available in FDA recall notice Z-0578-2025.
The recalled product
- Product
- Ziehm Vision RFD. Interventional fluoroscopic x-ray system
- Manufacturer
- Orthoscan, Inc.
- Hazard
- unintended-radiation
- hand-switch-failure
- mechanical-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 (20)
- UDI: EZIEZIEHMVISIONRFD1. Serial Numbers: 20048
- 20240
- 23805
- 21350
- 23249
- 23250
- 23251
- 23252
- 23253
- 23324
- 23375
- 23376
- 23377
- 23378
- 23379
- 23380
- 23381
- 23382
- 23412
- 23452
Distribution
Distribution scope not specified by the agency.
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