Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Getinge

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Getinge see related information
Date Initiated by Firm February 10, 2020
Date Posted February 18, 2020
Recall Status1 Terminated 3 on September 13, 2023
Recall Number Z-1475-2020
Recall Event ID 84884
Product Classification Disinfector, medical devices - Product Code MEC
Product Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying
Model Number: 88-5
Part Number: 88-103; 88-203
Code Information ITEM: 88-103:  Serial Numbers: SEV0725124 SEV0745196 SEV0832057 SEV0832058 SEV0833080 SEV0833081 SEV0910147 SEV0912065 W50010582 W50010772 W50010773 W50010774 W50011211 W50011212 W50011809 W50011810 W50011811 W50012589 W50013228 W50013359 W50013362 W50013363 W50013983 W50013984 W50014009 W50014080 W50014081 W50014082 W50014338 W50014339 W50014340 W50014425 W50014426 W50015254 W50015255 W50015480 W50015782 W50015964 W50015965 W50015966 W50015967 W50015968 W50017020 W50017021 W50017773 W50017953 W50017954 W50018081 W50018082 W50018188 W50018936 W50018937 W50019170 W50019172 W50020826 W50020827 W50021010 W50021068 W50021080 W50021115 W50021137 W50021169 W50021223 W50021224 W50021225 W50021228 W50021229 W50021326 W50021478 W50021526 W50021527 W50021528 W50021690 W50021723 W50022115 W50022118 W50023119 W50023347 W50023431 W50023468 W50023682 W50023712 W50023723 W50023770 W50023800 W50023801 W50023901 W50023933 W50023963 W50023989 W50024559 W50024606 W50025054 W50025079 W50025083 W50025142 W50025170 W50025204 W50025250 W50026016 W50026072 W50026778 W50026815 W50026954 W50026978 W50026996 W50027987 W50028001 W50028317 W50028353 W50028695 W50028733 W50028854 W50029123 W50029171 W50029201 W50030086 W50030180 W50030184 W50030715 W50031399 W50031975 W50032013 W50032606 W50032634 W50032635 W50032713 W50032773 W50032877 W50032977 W50032978 W50033103 W50033133 W50033645 W50033842 W50033930 W50033998 W50034018  Item Number: 88-203:  Serial Numbers: W50034751 W50035168 W50035183 W50035196 W50035635 W50035651 W50035687 W50035704 W50036689 W50036719 W50037076   UDI Code: 88-103 07340153700109; 88-203 07340153700116
Recalling Firm/
Manufacturer		 Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact SAME
973-709-7000
Manufacturer Reason
for Recall		 Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from contaminated water
FDA Determined
Cause 2		 Device Design
Action Getinge issued letter dated 2/10/20 Letters via FedEx Priority Overnight Delivery with Signature Proof of Delivery (SPOD).Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any affected Getinge 88-Series Washer Disinfectors (models 88-5) indicated by this notice; Once you have located the affected device, check to see if it is leaking underneath the machine or near the machines foot print. If the machine is leaking, call for Service Technician and plan for service. You can continue to use the machine but we recommend posting a sign for precaution. Units where leakage is observed will be prioritized in order to repair the unit. If your unit is found to be leaking due to this issue, it will be repaired free of charged. You can also arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9438872 (select option 1, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). Complete and sign the attached MEDICAL DEVICE RECALL - RESPONSE FORM (page 4) to acknowledge that you have received this notification.
Quantity in Commerce 146 US
Distribution Nationwide Foreign: Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Iran, Ireland, Israel, Italy, Japan, Kenya, Lithuania, Netherlands, New Zealand, Norway, Poland, Qatar, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom
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.
-
-