Z-1078-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- April 1, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 127
Product Description
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
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.
Distribution Pattern
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.
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