Recall Z-2392-2018 · MEC Disinfector, Medical Devices

Steris Corporation

Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and other miscellaneous reusable items used in the care of patients.

Date	May 23, 2018
Status	Terminated
Reason	The firm 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 level situation occurs, the alarm will only be generated at the unit s next power-up or when accessing service mode. The failure of the Reliance 1227 to identify that the chemicals used for cleaning are low or empty could result in bedpans and urinals, basins, case carts, beds, theater shoes and other miscellaneous reusable pat
Root cause	Software Design Change
Action	On May 23, 2018, the firm notified affected customers by Urgent Device Field Correction letters distributed via FedEx. The letter stated that the system software had been updated to correct the issue, and that a STERIS service technician would be contacting each facility to perform the system software update. In the interim of the software update, users were instructed to continue to verify the units chemistry levels daily as part of the facilitys Quality Management System. Chemistry containers with low chemistry volume should be replaced prior to initiating the next cycle. If you have que
Quantity	118
Distribution	Worldwide Distribution - US Nationwide in the states of AL, AK, CA, CO, CN, DE, FL, GA, IL, IA, KS, KY, LA, MA, MI, NJ, NY, ND, OH, OK, OR, PA, RI, SC, TN, TX, VT, VA, WI, and WV. Foreign distribution to Canada.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.