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U.S. Department of Health and Human Services

Class 2 Device Recall PET511BTM Multiplane transesophageal transducer (TEE)

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  Class 2 Device Recall PET511BTM Multiplane transesophageal transducer (TEE) see related information
Date Initiated by Firm May 11, 2009
Date Posted March 11, 2010
Recall Status1 Terminated 3 on March 22, 2012
Recall Number Z-1100-2010
Recall Event ID 53892
510(K)Number K072918  
Product Classification Ultrasonic pulsed echo imaging system - Product Code IYO
Product PET-511BTM Multi-plane transesophageal transducer (TEE) used with Toshiba Diagnostic Ultrasound System
Code Information All units
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92781-2068
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 70
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = TOSHIBA MEDICAL SYSTEMS CORPORATION
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