Siemens CT System Recalled for Image Artifacts and Safety Issues
Siemens Medical Solutions is recalling 12 SOMATOM Force CT systems due to potential image artifacts and safety-related software issues.
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 is classified as FDA Class II, and the source text identifies 'safety related issues' and 'image artifacts' without reporting specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 12 units of the SIEMENS SOMATOM Force computed tomography (CT) system. The affected units are equipped with software versions VA50A, VA50A_FP1, and/or VA50A_SP0. The recall is due to the possibility of image artifacts occurring during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and Head modes.
The recall also addresses other safety-related issues, including system start-up behavior, resuming, and ECG handling. The software update intended to resolve these issues improves the visual feedback for correct ECG lead placement and contact quality.
The affected units were distributed nationwide in Pennsylvania, Massachusetts, Minnesota, New York, South Carolina, Maryland, Illinois, Ohio, Texas, and Kentucky. Users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the software update.
The recalled product
- Product
- SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data f
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 12
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 (13)
- Model number: 10742326
- with serial numbers: 75454
- 75464
- 75437
- 75475
- 75481
- 75439
- 75450
- 75460
- 75476
- 75458
- 75467
- 75478.
Distribution
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