Siemens SOMATOM CT Systems Recalled for Potential Display Freeze Malfunction
Siemens Medical Solutions is recalling 147 SOMATOM CT systems due to a potential display freeze malfunction during clinical operation.
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 risk-of-harm product (medical device) where a malfunction could impact clinical operations, but no injuries or illnesses have been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 147 units of the SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. These are X-ray tomography, computed, radiology devices distributed nationwide.
The recall is due to a potential malfunction that may cause a system display freeze during clinical operation. This issue is associated with systems running software version syngo CT2012 B and syngo CT2013B.
The affected units include specific models and serial numbers listed in the agency record. No injuries or illnesses have been reported in the source text.
The recalled product
- Product
- Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 147
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)
- models 8098027
- 7740769
- 10430603
- 10590000
- with multiple serial numbers: 64789
- 64492
- 66767
- 66649
- 64067
- 66182
- 65364
- 64673
- 64419
- 66518
- 66243
- 64368
- 64081
- 60398
- 66929
- 66327
Distribution
Distributed nationwide across the United States.
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