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U.S. Department of Health and Human Services

Class 2 Device Recall Getinge 86Series

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 Class 2 Device Recall Getinge 86Seriessee related information
Date Initiated by FirmMay 20, 2019
Create DateJune 13, 2019
Recall Status1 Terminated 3 on December 15, 2023
Recall NumberZ-1777-2019
Recall Event ID 82975
Product Classification Disinfector, medical devices - Product Code MEC
ProductGetinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Code Information Serail Numbers: WAA088731, WAA089124 , WAA089128, WAA089586
Recalling Firm/
Manufacturer		 Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information ContactSAME
973-709-7000
Manufacturer Reason
for Recall		Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionGetinge issued a An Urgent Medical Device Correction to U.S. consignees on 5/20/19 via FedEx 2 day Delivery with Signature Proof of Delivery (SPOD). Letter provides identification of the issue, health risk and action to take: examine your inventory immediately, Until the required correction has been completed, take the following precautions detailed in the User Manual: Do not operate the machine unattended. Always inspect the processed goods after a wash cycle. Contact a Getinge Service person if either of these are noticed: o If the washer starts to sound different than usual during a wash cycle, abort the process and call your service person.o Goods are not cleaned after the process is finished. Getinge Service person will contact the person you listed on the Customer Response Form to schedule service for an update of your device, free of charge. You can also arrange a visit by a Getingetrained or authorized service technician by calling Getinge Customer Support at 18009509912 (select option 1). Customer Service hours: 8:00 AM to 5:00 PM (EST) Monday to Friday
Quantity in Commerce4 units
DistributionWorldwide Distribution - US Nationwide GA, IL, IN, MI, NC, OR, PA, VA Foreign: Australia, Canada, China, France, Germany, India, Japan, Korea, Netherlands, Saudi Arabia, South Africa, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Ukraine
Total Product Life CycleTPLC 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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