Siemens Recalls V5Ms Transesophageal Ultrasound Transducers Due to Material Deterioration
Siemens is recalling 321 V5Ms transesophageal ultrasound transducers because the material covering the articulating section has deteriorated.
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, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 321 units of the V5Ms transesophageal transducer. The recall is due to reports of deterioration of the material covering the articulating section of the device. The V5Ms transducer is intended primarily for cardiology applications.
The affected units were distributed worldwide, including nationwide in the United States and in numerous international markets. The recall includes specific model numbers 8264577 and 8263703, along with a list of specific serial numbers for both US and international (ROW) units.
Healthcare facilities and users should stop using the affected transducers and contact Siemens Medical Solutions USA, Inc. for further instructions on the recall.
The recalled product
- Product
- V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 321
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 numbers 8264577 and 8263703
Distribution
Distributed nationwide across the United States.
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