X-ray system hand switch may fail, risking unintended radiation exposure
Three Ziehm Vision x-ray systems have hand switches that may fail under mechanical stress, potentially causing unintended radiation. Owners should verify their serial numbers and contact the manufacturer.
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 defective component that presents a risk of unintended radiation exposure. However, no illnesses or injuries have been reported. Per the severity rubric, this is classified as High (score 3) because it involves a risk-of-harm product without reported injury.
Plain-English summary
Three Ziehm Vision computed tomography x-ray systems (Serial Numbers: 9246, 90155, 90416) are subject to a recall. These devices are manufactured by Ziehm Imaging GmbH and distributed by Ziehm Imaging, Inc. The devices were distributed throughout the United States and Puerto Rico.
The wired hand switch on these systems may fail when exposed to mechanical stress such as dropping or impacts. Failure of the switching element can potentially initiate unintended radiation from the connected x-ray unit. The devices do not fully meet the requirements of IEC 60601-2-54 and 21 CFR 1020.32(c).
Facility operators should verify the serial numbers of their Ziehm Vision systems to determine if their equipment is affected. Facility staff with affected equipment should contact Ziehm Imaging, Inc. or Ziehm Imaging GmbH for guidance regarding this recall.
The recalled product
- Product
- Ziehm Vision system, x-ray, tomography, computed.
- Manufacturer
- Orthoscan, Inc.
- Category
- Medical Device — X-Ray Equipment
- Hazard
- unintended-radiation
- 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 (3)
- UDI: EZIEZIEHMVISIONFD1 Serial Numbers: 9246
- 90155
- 90416.
Distribution
Distribution scope not specified by the agency.
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