Siemens CT Systems Recalled for Software Bugs Causing Scan Aborts
Siemens Medical Solutions is recalling 1,096 CT systems due to software bugs that may cause scan aborts, rescans, or accidental x-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 product (CT scanner) where injury (accidental x-radiation) has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,096 units of the SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash, and SOMATOM Definition Edge computed tomography (CT) x-ray systems. These devices are intended to produce cross-sectional images of the body. The recall affects systems running on software versions VA44A_SP3a, VA44A_SP3b, and VA44A_SP3c.
The recall is due to software bugs that could possibly cause scan aborts. These issues may lead to rescans of patients with additional radiation dose, delayed diagnosis, or the need for additional contrast medium. In worst-case scenarios, the bugs could possibly cause accidental x-radiation to the user or impede customer workflow.
The affected units were distributed nationwide, including the District of Columbia, Puerto Rico, and all 50 states. Healthcare facilities using these specific models and software versions should contact Siemens Medical Solutions for further instructions on remediation.
The recalled product
- Product
- Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; 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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