Siemens Artis zee Ceiling Systems Recalled for Cable Damage Risk
Siemens Medical Solutions USA is recalling 284 Artis zee Ceiling Systems due to potential cable damage from sub-optimal guidance.
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 3/5 (High).
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: The recall involves a medical device with a defect that can lead to cable damage, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 284 units of the Artis zee Ceiling Systems, an angiographic x-ray system. The recall covers serial numbers from 146352 to 147617. These products were distributed nationwide.
The recall is being issued because there is an increased wear due to potential sub-optimal cable guidance during the lifetime of the systems. This condition can lead to cable damage. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the cable guidance issue and prevent damage.
The recalled product
- Product
- Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 284
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 (1)
- Artis zee Ceiling systems serial numbers from 146352 to 147617
Distribution
Distributed nationwide across the United States.
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