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U.S. Department of Health and Human Services

Class 2 Device Recall Getinge

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 Class 2 Recall
Getinge
see related information
Date Posted July 26, 2012
Recall Status1 Open
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, New York 14623-3133
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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