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Getinge Usa Sales Inc recalls Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Recalled May 25, 2022 · FDA recall Z-1078-2022 · Getinge Usa Sales
Hazard
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 Class II
Units
127
Sold at
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.
Description
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.
Product
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Manufacturer(s)
Getinge Usa Sales Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →