Ziehm Vision RFD 3D Hand Switch Defect May Cause Unintended Radiation
The Ziehm Vision RFD 3D hand switch can fail when exposed to mechanical stress like dropping, potentially initiating unintended radiation from the x-ray system.
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 recalls are typically scored at 4 (Severe) when injury or hospitalization is reported. However, the source text contains no report of injuries or illnesses—only the potential for unintended radiation. Per the rubric, theoretical risk-of-harm without reported injury scores at most 3 (High).
Plain-English summary
Orthoscan, Inc. has issued a Class II recall of the Ziehm Vision RFD 3D Interventional Fluoroscopic X-ray System affecting 50 devices distributed throughout the United States and Puerto Rico. The recalled units are identified by specific serial numbers ranging from 21118 to 23849.
The wired hand switch on these devices may not fully meet regulatory requirements (IEC 60601-2-54 and 21 CFR 1020.32(c)). When exposed to mechanical stress—such as drops or impacts—the switch's internal components can be irreversibly damaged, potentially causing unintended radiation emission from the x-ray unit.
Healthcare facilities and medical professionals using any of the 50 affected serial numbers should contact Orthoscan, Inc. or the distributor, Ziehm Imaging, Inc., for guidance. Do not operate affected units if the hand switch shows signs of mechanical damage or stress.
The recalled product
- Product
- Ziehm Vision RFD 3D. Interventinoal 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 (20)
- UDI: EZIEZIEHMVISIONRFD3D1. Serial Numbers: 21118
- 21212
- 22040
- 22710
- 22764
- 23247
- 23248
- 23255
- 23257
- 23258
- 23259
- 23260
- 23327
- 23328
- 23329
- 23456
- 23457
- 23458
- 23459
- 23653
Distribution
Distribution scope not specified by the agency.
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