Siemens Multix Fusion Radiographic Systems Recalled for Lifting Column Cable Defect
Siemens is recalling 35 Multix Fusion radiographic systems because steel cables in the lifting column may rupture without triggering the safety lock, causing the arm to drop unexpectedly.
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 recall is classified as FDA Class II and involves a structural defect in a medical device that could cause the arm to drop unexpectedly, posing a significant injury risk.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 35 units of the Multix Fusion radiographic system. The affected models include the Multix Fusion Analog, Digital Portable, Digital Integrated, and Digital Wireless, all equipped with the Tube stand 3D V. The recall covers units distributed nationwide in the United States.
The recall is due to a defect in the steel cables inside the lifting column of the overhead tube. These cables may rupture without triggering the safety lock. This failure can lead to mechanical fatigue and cause the arm to drop down unexpectedly during vertical movement or patient positioning.
Healthcare facilities and users of these specific serial numbers should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the defect. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 35
Distribution
Distributed nationwide across the United States.
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