Device Recall PET511BTM Multiplane transesophageal transducer (TEE) 의 리콜

Recall

53892

Class 2

Z-1100-2010

2009-05-11

2010-03-11

Terminated

United States

2012-03-22

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86818

Toshiba america medical systems inc is removing the pet-511btm multi-plane transesophageal transducer from the market after receiving several reports of injury regarding the transducer. bending or buckling of the flexible portion of the pet-511 btm multi-plane transesophageal transducer (tee) may result in injury including perforation.

Toshiba America Medical Systems sent a Field Safety Notice to all customers on 5 MAY 2009 indicating its intent to remove the units from the market. The letter requested immediate cessation of use and return to the manufacturer site. It announced plans to replace unit with a new multi-plane transducer at no addle charge. The notice also included a description of the problem that occurred, the proper insertion technique into the esophageal passage, how to avoid and detect bending or buckling of the transducer, and what to do if the transducer does buckle. A revised safety manual and poster reflecting these precautions for the PET-51 IBTM was sent to each customer using this transducer. Shipments of the transducer from December 2008 also contained the Field Safety Notification materials. For additional information, contact the firm at (714) 669 2458.