Medical Device Recall: Z-0018-2014

FDA Recalls dataset · Firm: Getinge Disinfection Ljungadalsgatan · Status: Terminated

Recall Action Class: N/A Date Initiated: 2013-07-30 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0018-2014.

Recall Res Number
Z-0018-2014
Recalling Firm / Manufacturer
FEI Number
3000231474
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2013-07-30
Date Posted
2013-10-17
Date Terminated
2015-05-11
Product Code
MEC
Event Number
66000
Product Quantity
143 units (142 domestically & 1 unit internationally)
Product Description 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.

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.

Action Details 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.

Distribution Pattern 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.

Code Information / Serial Numbers Model # 46-4,  Serial # range SEV0521184-SEV0838137

Related Establishments / Registrations

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