Device product
The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
Z-2779-2015
Product summary
- Event
- Event 71910
- Status
- Terminated
- Classification
- Class III
- Quantity
- 901
- Official record key
device-enforcement:Z-2779-2015
Official wording
Reason: The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure.
Code information: Product Code: Leica ASP200S/ASP300S with Serial Numbers: 5682; 5886; 5264; 5267; 5356; 5259; 5956; 5946; 5794; 5385; 5929; 5301; 5401; 5310; 5530; 5909; 5804; 5272; 5724; 5796; 5807; 5446; 5435; 5670; 5947; 5348; 5434; 5388; 5366; 6000; 6131; 5407; 6040; 5799; 5815; 5737; 5706; 5381; 5416; 5673; 5875; 5962; 6041; 6042; 5266; 5948; 5693; 6021; 5610; 5798; 5926; 5387; 5349; 5273; 6115; 5612; 5965; 5955; 5260; 5725; 5871; 5873; 5874; 5562; 6046; 5386; 5977 ;5889; 5398; 6062; 5609; 6015; 5734; 5403; 5289; 5426; 6149; 5663; 6045
Distribution pattern: Worldwide Distribution - US including U.S. including AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, TX, VA, WA, WI, WV and District of Columbia. Internationall to AE, AT, AU , BD , BE, BF, BG,BR, CA, CL, CN, CO, CR, DE, DK, EC, EG, ES, ET, FI, FR, GB, HU, ID, IN, IT, JM, JP, KR, LK, MA, MT, MY, NL, NZ, PA, PE, PH, PL, PT, RO, RU, SA, SE, SG, TH, TR, TW, VN and ZA.
Derived failure modes
-
Unknown
The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure.