Varian On-Board Imager Elbow Motor Shaft Recall
Varian Medical Systems is recalling On-Board Imager devices with Type 01 elbow motors due to a shaft failure caused by belt over-tensioning.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, indicating a theoretical or low-risk mechanical hazard.
Plain-English summary
Varian Medical Systems, Inc. is recalling 2,622 units of the On-Board Imager (OBI) device. The recall involves the Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) equipped with "Type 01" elbow motors. The On-Board Imager is an x-ray device used to evaluate patient position relative to the isocenter and verify treatment fields in relation to anatomical and fiducial landmarks.
The recall was initiated because Varian identified a failure with the shaft of the Type 01 elbow motor. This failure is attributed to belt over-tensioning. The affected units were distributed worldwide.
Healthcare facilities and users should check their equipment for the specific model and code numbers listed in the official recall notice. If the equipment matches the description, users should follow the instructions provided by Varian Medical Systems for inspection or repair.
The recalled product
- Product
- On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in…
- Manufacturer
- Varian Medical Systems, Inc.
- Hazard
- Affected units
- 2,622
Distribution
Distribution scope not specified by the agency.
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