The Recall Desk
ModerateFDA (Devices)·Z-2571-2014·Announced 2014-09-10

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.

What this means for you

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
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.

Same manufacturer · Siemens Medical Solutions USA, Inc.

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Same hazard · material deterioration

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