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U.S. Department of Health and Human Services

Class 2 Device Recall Getinge 9100Series

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  Class 2 Device Recall Getinge 9100Series see related information
Date Initiated by Firm April 01, 2022
Create Date May 13, 2022
Recall Status1 Open3, Classified
Recall Number Z-1078-2022
Recall Event ID 89998
Product Classification Disinfector, medical devices - Product Code MEC
Product Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Code Information UDI Codes: [07340153710023, 07340153710047, 07340153710054, 07340153710061, 9122EW 07340153710030, 07340153710078.] Serial Numbers: WAA088008, WAA088276, WAA089054, WAA089188, WAA089511, WAA091312, WAA092134, WAA097871, WAA098978, WAA087395, WAA087675, WAA087676, WAA088563, WAA088677, WAA088684, WAA088798, WAA088973, WAA090326, WAA090827, WAA090829, WAA091562, WAA092656, WAA092905, WAA093809, WAA094122, WAA094447, WAA095653, WAA095654, WAA095655, WAA096084, WAA096723, WAA096820, WAA099698, WAA100249, WAA100596, WAA100828, WAA102416, WAA102300, WAA102301, WAA086373, WAA088830, WAA089854, WAA089735, WAA089736, WAA090141, WAA090273, WAA090274, WAA091427, WAA093786, WAA094342, WAA095013, WAA095014, WAA096724, WAA098589, WAA099164, WAA098725, WAA100514, WAA100695, WAA100704, WAA100832, WAA101375, WAA100834, WAA101893, WAA076270, WAA085559, WAA086376, WAA086914, WAA086915, WAA088007, WAA088273, WAA088464, WAA088465, WAA087754, WAA088678, WAA088685, WAA088871, WAA088998, WAA089258, WAA089356, WAA089446, WAA089970, WAA089969, WAA090495, WAA090615, WAA090746, WAA091561, WAA091184, WAA091560, WAA091563, WAA091564, WAA091869, WAA091870, WAA091873, WAA091868, WAA092136, WAA091872, WAA092904, WAA093646, WAA093882, WAA093967, WAA094123, WAA094202, WAA094284, WAA094285, WAA094286, WAA094617, WAA094601, WAA095421, WAA096425, WAA096427, WAA096428, WAA097298, WAA098056, WAA099694, WAA099450, WAA099451, WAA099695, WAA099697, WAA100127, WAA100826, WAA100827, WAA100830, WAA101342, WAA101894, WAA103173, WAA088274, WAA093968
Recalling Firm/
Manufacturer		 Getinge Usa Sales Inc
1 Geoffrey Way
Wayne NJ 07470-2035
For Additional Information Contact Ms. Marylou Insinga
973-709-7442
Manufacturer Reason
for Recall		 Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.
FDA Determined
Cause 2		 Other
Action An Urgent Medical Device Notification was issued 04/01/2022 via FedEx which includes serial numbers for affected devices. Customers are to verify they have an affected device and submit the attached Response Form. Distributors are to forward notification on to customers. Getinge service technicians will contact customers to schedule corrective actions. You can continue to use the Getinge Series 9100E-series Washer Disinfector with G1 control systems until the corrective action is performed, there are no precautionary actions necessary. Contact your Getinge representative with questions or for Technical Support call (888) 943-8872 (options 4,2,1), Monday through Friday, 8:00 a.m. - 6:00 p.m EST, or email techsupportIC.us@getinge.com.
Quantity in Commerce 127
Distribution Worldwide distribution: (US) AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, SD, TX, VA, WA, WV. (OUS) Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Italy, Japan, Kuwait, Libya, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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