Swissray Medical Recalls ddRCombi Plus FP X-ray Systems Due to Lifting Column Defect
Swissray Medical AG is recalling three ddRCombi Plus FP X-ray systems because a lifting column component may break, causing the arm to drop and potentially seriously injure patients or users.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that patients and users may be seriously injured if the arm drops unexpectedly, which aligns with the rubric criteria for a score of 4 (Severe) involving significant injury reports or risks.
Plain-English summary
Swissray Medical AG is recalling three units of the ddRCombi Plus FP, a fully digital, multifunctional X-ray system used for orthopedics, trauma, and pulmonary imaging. The affected model numbers are 8.2000.0070.0 (US Version) and 8.2000.0060.0 (Europe Version). The specific serial numbers for the recalled units are S403088, S403089, and S403165.
The recall is due to a defect in a component supplied by a third party. In rare cases involving inadequate maintenance or very high clinical workload, the first steel wire rope of the lifting column may break without triggering the safety lock. This failure can overload the safety cable, which is not designed to permanently carry the load or move continuously under load. This condition can lead to material fatigue and cause the X-ray arm to drop unexpectedly during patient positioning.
The affected devices were distributed worldwide, including in the United States (Illinois and Massachusetts) and in the Czech Republic, Germany, Poland, and Peru. If the arm drops unexpectedly, patients and users may be seriously injured. Users should contact Swissray Medical AG for further instructions on how to address this defect.
The recalled product
- Product
- ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all…
- Manufacturer
- Swissray Medical AG
- Affected units
- 3
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)
- Serial Numbers: S403088
- S403089
- S403165
Distribution
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