Agency classClass IIOur severity:Severe FDA (Devices)·Z-1305-2016·Announced 2016-04-06

Siemens Recalls SOMATOM CT Systems Due to Cardio License Malfunction

Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction in cardio licenses that could hazard patients and personnel.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II, and the source text explicitly states a 'potential hazard to patients and personnel,' which aligns with the rubric criteria for a Severe rating (FDA Class II with significant injury/property-damage reports or structural defects).

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 124 units of the SOMATOM Emotion and SOMATOM Sensation families of CT systems. These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. The recall is initiated due to a potential malfunction associated with the use of the cardio licenses "Cardio Pro" and "Cardio Retro."

The malfunction presents a potential hazard to patients and personnel when the systems are used in conjunction with these specific licenses. The affected units were distributed nationwide in the United States, including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA.

The FDA has classified this recall as Class II. Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the malfunction and ensure the safety of patients and personnel.

The recalled product

Product: Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems 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 different angles or spiral planes taken at…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — CT Systems
Hazard: malfunction
patient-hazard
Affected units: 124

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 (1)

Model Number: SOMATOM Sensation 64/ Cardiac 64 - 8377520

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

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