V5Ms transesophageal transducer (used for ultrasound imaging) 의 리콜

Recall

RC-2014-RN-00943-1

Class I

2014-08-29

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00943-1

Seiemens has received recent overseas reports about the deterioration of material covering the articulating section of the v5ms transesophogeal transducer. although to date, no patient injury has been reported, a compromise or fault in this material combined with a failure to use a probe cover as directed in the user manual may cause oesophageal cuts, bleeding, and perforation to the patient, and severe trauma, electrical burns, and serious electrical hazards to the patient and the user. however, a leakage current test can indicate cracks, cuts, tears, perforations, and protrusions in the articulation material.

To avoid the potential risk associated with this issue, customers are asked to undertake the following steps: - Perform the leakage current test for a transesophageal transducer prior to each use. - Use only Siemens approved cleaning and disinfecting solutions. - Use market-cleared transducer sheaths specifically designed for TEE applications. - When users store the transesophageal transducer, take extreme care that the distal tip is straight. Never move the distal tip by hand. Always use the flex controls. Customers are advised that if they notice any damage or wear on the transducer, or if the transducer fails to pass the leakage current test, immediately discontinue use of the transducer and contact their local Customer Service Engineer. This action has been closed-out on 06/06/2016.