AMSCO 5052 Single-Chamber Washer/Disinfector (2018-12-23)
- Starting date:
- December 23, 2018
- Posting date:
- January 23, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-68840
Affected products
AMSCO 5052 Single-Chamber Washer/Disinfector
Reason
STERIS has identified that the software in the AMSCO 3052 and 5052 Single-Chamber Washer/Disinfectors equipped with an automated SCS Conveyor and barcode system may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.
Affected products
AMSCO 5052 Single-Chamber Washer/Disinfector
Lot or serial number
- S/N: 3601518012
- S/N: 3603618005
- S/N: 3612718013
- S/N: 3632318009
- S/N: 3601518006
Model or catalog number
- FH14-043
- FH14-072
- FH14-XXXX
Companies
- Manufacturer
-
Steris Canada Corporation
490 Boul. Armand-Paris
Quebec
G1C 8A3
Quebec
CANADA