Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1645-2015·Announced 2015-06-03

Siemens SOMATOM Emotion 16 CT Scanner Software Recall

Siemens is recalling 75 SOMATOM Emotion 16 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 software bugs causing operational issues (crashes, freezes) that may require rescans, without reporting any hospitalizations, serious injuries, or deaths. This fits the criteria for a moderate severity recall involving operational defects rather than direct physical harm.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 75 units of the SOMATOM Emotion 16 computed tomography (CT) scanner. The recall is due to software bugs in VC20B SP0a or SP1 software versions that may cause system instability. These issues 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 locks under heavy multitasking.

The affected scanners were distributed nationwide, including Puerto Rico. The specific serial numbers for the 75 affected units are listed in the agency's recall record. The primary risk associated with these software defects is that they may make it necessary to rescan patients, which could result in additional radiation exposure or delays in medical care.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. to arrange for software updates or repairs. Patients who have undergone scans on these devices should consult their healthcare providers if they have concerns about the quality of their images or the need for repeat procedures.

The recalled product

Product: SOMATOM Emotion 16, 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
Category: Medical Device — Computed Tomography (CT) Scanner
Hazard: software-defect
operational-error
Affected units: 75

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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