Siemens SOMATOM Definition AS CT Systems Recalled for Software Bugs
Siemens is recalling 1,096 SOMATOM Definition AS 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 medical device with potential for accidental radiation exposure and delayed diagnosis, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,096 units of the SOMATOM Definition AS computed tomography (CT) x-ray system. These devices are intended to produce cross-sectional images of the body. The recall affects model number 8098027 running on software versions VA44A_SP3a, VA44A_SP3b, and VA44A_SP3c.
The recall is due to software bugs that could possibly cause scan aborts, requiring rescans of patients with additional radiation dose. These issues may also lead to delayed diagnosis, the need for additional contrast medium, accidental x-radiation to the user, or impeded customer workflow.
The affected units were distributed nationwide, including DC, Puerto Rico, and all 50 states. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the software update or replacement.
The recalled product
- Product
- Siemens SOMATOM Definition AS; 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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