Siemens SOMATOM Perspective CT Scanner Software Recall
Siemens is recalling 75 SOMATOM Perspective CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes operational software bugs (crashes, freezes) without reporting any injuries, illnesses, or deaths. This aligns with a moderate severity rating for a voluntary precautionary recall of a medical device where the primary risk is operational disruption rather than direct physical harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 75 units of the SOMATOM Perspective computed tomography (CT) scanner. The recall is due to software bugs in VC20B SP0a or SP1 software versions that may cause operational issues, including system crashes, image freezes, or database locks.
The identified software defects include the Syngo Main UI crashing when the Patient Browser is scrolled with keyboard arrow keys, Tomo images freezing on the screen when zoomed in or out under CAREVision mode, sporadic displaying errors in the WorkStream4D application, and database locking under heavy multitasking conditions. These issues could make it necessary to rescan patients.
The affected units were distributed nationwide, including Puerto Rico. Siemens is the recalling firm. Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on software updates or repairs.
The recalled product
- Product
- SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 75
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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