Siemens Recalls CT Systems for Software Safety Bug Fixes
Siemens is recalling seven CT systems to install a software update that fixes bugs and corrects potential safety 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 involves a medical device with potential safety issues, but the source text does not report any hospitalizations, injuries, or deaths, placing it in the High severity category per the rubric.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling seven SOMATOM Definition Flash computed tomography (CT) x-ray systems. The recall involves specific serial numbers: 96020, 96047, 74192, 83398, 96011, 83387, and 96029. The affected systems were distributed nationwide to facilities in Michigan, New York, California, Kentucky, North Dakota, and Nebraska.
The recall is being conducted to release a software update that provides bug fixes to improve system performance. This update also includes a correction for the Care Contrast license to address potential safety issues. The agency has classified this recall as Class II.
Facilities with these specific systems should contact Siemens Medical Solutions USA, Inc. to schedule the installation of the software update. No specific consumer actions are required for the general public, as these are medical devices used in clinical settings.
The recalled product
- Product
- SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at diff
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 7
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 (6)
- Model Number: 10430603 Serial Numbers:96020
- 96047
- 74192
- 83398
- 96011
- 83387 96029
Distribution
Part of a larger recall action
This product is one of 3 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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