Z-1100-2010

PET-511BTM Multi-plane transesophageal transducer (TEE) used with Toshiba Diagnostic Ultrasound System

Name: Z-1100-2010 PET-511BTM Multi-plane transesophageal transducer (TEE) used with Toshiba Diagnostic Ultrasound System
Creator: Toshiba American Medical Systems Inc
Published: 2009-05-11
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2009-05-11 / Terminated / root cause: design

FDA source

Toshiba American Medical Systems Inc began a recall of PET-511BTM Multi-plane transesophageal transducer (TEE) used with Toshiba Diagnostic Ultrasound System on 2009-05-11. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1100-2010
Status: Terminated
Initiated: 2009-05-11
Posted: 2010-03-11
Terminated: 2012-03-22
Recalling firm: Canon Medical Systems USA, Inc.
Product: PET-511BTM Multi-plane transesophageal transducer (TEE) used with Toshiba Diagnostic Ultrasound System
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
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.
Root cause tag: design
FDA root cause: 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
Product codes and lots: All units

Product code IYO

K072918Class IIModel Ssa-680A Xario Xg Diagnostic Ultrasound System, Version 1.00Toshibamedical Systems Corporation / cleared 2007-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)