Reliance 1227 Cart and Utensil Washer/Disinfector (2018-05-21)
- Starting date:
- May 21, 2018
- Posting date:
- July 27, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67310
Affected products
Reliance 1227 Cart and Utensil Washer/Disinfector
Reason
STERIS has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector's "Chemical Low Level" alarm, intended to prevent the user from initiating a cycle when a low chemical level situation occurs, does not operate as intended. Currently, if a low chemical situation occurs, the alarm will only be generated at the unit's next power-up or when accessing service mode. Assuming pre-cleaning and post-processing visual inspection activities are completed in accordance with Good Hospital Practice, the Reliance 1227 Cart Washer's thermal disinfecting properties are not affected by the software issue identified.
Affected products
Reliance 1227 Cart and Utensil Washer/Disinfector
Lot or serial number
S/N: 3605113001
S/N: 3605415029
S/N: 3608215021
S/N: 3608718001
S/N: 3611417015
S/N: 3616714023
S/N: 3616814019
S/N: 3630814002
S/N: 3632116001
S/N: 3633015001
Model or catalog number
FW03-101
FW03-102
Companies
- Manufacturer
-
Steris Canada Corporation
490 Boul. Armand-Paris
Quebec
G1C 8A3
Quebec
CANADA