Recall Z-2571-2014— Siemens Medical Solutions USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2014-08-13, terminated 2015-03-06. It names one FDA 510(k) clearance: K121807. Product: V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications. Reason: Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer..
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-13
- Terminated
- 2015-03-06
- Firm location
- Mountain View, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications
Reason for recall
Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer.
Data sourced from openFDA. This site is unofficial and independent of the FDA.