|
Class 2 Device Recall Getinge |
|
Date Initiated by Firm |
May 25, 2012 |
Date Posted |
July 26, 2012 |
Recall Status1 |
Terminated 3 on May 18, 2016 |
Recall Number |
Z-2079-2012 |
Recall Event ID |
61974 |
Product Classification |
Disinfector, medical devices - Product Code MEC
|
Product |
Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128 |
Code Information |
Serial numbers: W50024258; W50024259; W50026573; W50025790; W50017381; W50020296; W50028138; W50020952 |
Recalling Firm/ Manufacturer |
Getinge USA Inc 1777 E Henrietta Rd Rochester NY 14623-3133
|
For Additional Information Contact |
585-475-1400
|
Manufacturer Reason for Recall |
Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through 09-26-2011. This action is based on a report from the ground fault breaker manufacturer of a production error.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Getinge USA issued a Device Correction Notice dated June 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to perform a trip test to determine if they have a functioning ground fault breaker. Customers will be contacted by a Getinge representative to schedule an appointment to exchange the earth fault breaker. Customers were provided a Customer Response Form to complete and fax back to 585-272-5033. For questions customers should call 800-475-9040, ext. 5270.
For questions regarding this recall call 585-475-1400. |
Quantity in Commerce |
8 washers |
Distribution |
Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada |
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.
|
|
|
|