Events

Recall of Device Recall Amsco Ultrasonic instrument cleaner

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Steris Corporation.

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
    35737
  • Event Risk Class
    Class 2
  • Event Number
    Z-1408-06
  • Event Initiated Date
    2006-06-22
  • Event Date Posted
    2006-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46705
  • 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 instrument cleaner - Product Code FLG
  • Reason
    Smoke, sparking and fire hazard-units manufactured between november 2000 and january 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result in smoking, sparking, and fire.
  • Action
    The firm sent out a certified letter to all affected consignees alerting them to problems with the device on 6/22/06.

Device

Device Recall Amsco Ultrasonic instrument cleaner
  • Model / Serial
    All units bearing serial numbers 0432000018 to 0403105051.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide USA and countries of Japan, Canada, Hong Kong, Korea, Lebanon, Qatar, Poland, Russia, Saudi Arabia, Singapore, Taiwan, Germany, Northern Mariana Islands, and Malaysia.
  • Product Description
    Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015, B018905016, B018905017, B018905018, B018905JAE, B018905JAESS, B018905JAESSI, B018905JAG, B018905JAGSS
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Address
    Steris Corporation, 2720 Gunter Park Dr E, Montgomery AL 36109-1410
  • Source
    USFDA