Siemens SOMATOM Definition Flash CT Systems Recalled for Software Bugs
Siemens Medical Solutions is recalling 1,096 CT systems due to software bugs that may cause scan aborts, rescans, or accidental radiation.
What this means for you
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 (accidental radiation) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,096 units of the SOMATOM Definition Flash computed tomography (CT) x-ray system. The recall affects model number 10430603 running on software versions VA44A_SP3a, VA44A_SP3b, or VA44A_SP3c. These systems are intended to produce cross-sectional images of the body.
The recall is due to software bugs that could possibly cause scan aborts, requiring rescans of patients with additional radiation dose. In worst-case scenarios, the bugs could cause the need for additional contrast medium, accidental x-radiation to the user, or impede customer workflow. The systems were distributed nationwide, including DC, Puerto Rico, and all 50 states.
Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the software issues.
The recalled product
- Product
- Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 1,096
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 (2)
- VA44A_SP3b
- VA44A_SP3c.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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