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U.S. Department of Health and Human Services

Class 2 Device Recall Getinge 46Series

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  Class 2 Device Recall Getinge 46Series see related information
Date Initiated by Firm July 30, 2013
Date Posted October 17, 2013
Recall Status1 Terminated 3 on May 11, 2015
Recall Number Z-0018-2014
Recall Event ID 66000
Product Classification Disinfector, medical devices - Product Code MEC
Product Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196

Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Code Information Model # 46-4,  Serial # range SEV0521184-SEV0838137 
Recalling Firm/
Manufacturer		 Getinge Disinfection
Ljungadalsgatan 11
Vaxjo Sweden
Manufacturer Reason
for Recall		 Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Getinge USA, Inc. sent a Device Correction Notices letter dated July 26, 2013 to all affected customers via US Postal Certified Mail within the U.S. and Canada. The letter identified the affected product, problem and actions to be taken. The letter indicate that all customers will be contacted by a Getinge representative for guidance if any machine within the serial number range of affected product is within their possession. If you should have any questions or concerns regarding this field correction, please call 1-800-475-9040, press "1" and enter extension 5036.
Quantity in Commerce 143 units (142 domestically & 1 unit internationally)
Distribution USA Nationwide in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and internationally in 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.
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