Siemens SOMATOM Definition CT Systems Recalled for Software Bugs
Siemens Medical Solutions USA is recalling 1,096 SOMATOM Definition CT systems due to software bugs that may cause scan aborts, re-scans, 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 high-risk medical device where software bugs could cause accidental x-radiation to users and patients, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,096 units of the SOMATOM Definition family of computed tomography (CT) x-ray systems. The affected systems are model number 7740769 and are running on software versions VA44A_SP3a, VA44A_SP3b, or VA44A_SP3c. These devices are intended to produce cross-sectional images of the body.
The recall is due to software bugs that could possibly cause scan aborts, requiring re-scans 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, potentially leading to delayed diagnosis.
The affected units were distributed nationwide, including the District of Columbia, Puerto Rico, and all 50 states. Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software issues.
The recalled product
- Product
- Siemens SOMATOM Definition: 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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