Siemens CT Systems Recalled Due to Rubber Damper Degradation Risk
Siemens Medical Solutions is recalling 345 CT systems because a rubber damper may degrade and break, potentially causing motor mounting plates to loosen and injuring operators or patients.
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 3/5 (High).
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 involves a risk of injury to operators and patients from a mechanical component failure, but the source text does not report any actual 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 345 units of the SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography (CT) systems. The recall is due to a defect where the rubber damper may degrade and break. This degradation can cause the motor mounting plates to loosen, creating a risk of injury to both the operator and the patient.
The affected units were distributed nationwide in the United States, specifically in the states of Iowa, Texas, Florida, Nebraska, New York, Ohio, North Carolina, Kansas, Illinois, California, and Oklahoma, as well as Puerto Rico. The recall covers specific material numbers 10165977, 10045692, and 10165888, along with a list of specific serial numbers provided in the official notice.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. to arrange for the necessary corrective actions to address the rubber damper issue and ensure the safety of the equipment.
The recalled product
- Product
- Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: 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…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 345
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 (2)
- Material numbers: 10165977
- 10045692
Distribution
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