Events

Recall of Device Recall PET511BTM Multiplane transesophageal transducer (TEE)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toshiba American Medical Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53892
  • Event Risk Class
    Class 2
  • Event Number
    Z-1100-2010
  • Event Initiated Date
    2009-05-11
  • Event Date Posted
    2010-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86818
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ultrasonic pulsed echo imaging system - Product Code IYO
  • Reason
    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.
  • 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.

Device

Device Recall PET511BTM Multiplane transesophageal transducer (TEE)
  • Model / Serial
    All units
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    PET-511BTM Multi-plane transesophageal transducer (TEE) used with Toshiba Diagnostic Ultrasound System
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Manufacturer Address
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA