Recall of (1) BK rectal transducer (2) handheld external transducer (3) removed (4) rectal transducer 8848 type (5) BK transducer for nonvascular surgery (6) transducer type 8838 ) Surgical transducer 8816 type (8) remove

According to Pharmaceuticals and Medical Devices Agency, Japan, this recall involved a device in Japan that was produced by ICST Co., Ltd..

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
    2-7259
  • Date
    2016-12-27
  • Event Country
  • Event Source
    PMDAJ
  • Event Source URL
  • Notes / Alerts
    Japanese data is current through August 2018. All of the data comes from the Japanese Pharmaceuticals and Medical Devices Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Japan.
  • Extra notes in the data
    2017/1/18 "1. General name and sales name", "2. Target lot, quantity and shipping time", "7. Effect, effect or use etc." 2017/3/2 "2. Target lot , Quantity and shipping time "," 7. Correction of the indication, effect, use, etc "

Device

  • Model / Serial
  • Product Description
    (1), (4), (6) ultrasonic diagnostic probe for rectum (2) handheld external ultrasonic diagnostic probe (3) (8) deletion (5), (7) for nonvascular surgery Ultrasonic diagnostic probe
  • Manufacturer

Manufacturer

  • Source
    PMDAJ