Company:Steris Corp
Date of Enforcement Report 12/15/11
Class ll:
PRODUCT
SCC Soft Computer, Softlab Laboratory information System with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3. Recall #Z-0278-2012.
REASON
Potential for patient data to be sent to the wrong patient record. A software change affected how the Softlab handles recovery from certain types of table access conflicts. When such conflicts occur, this function has the potential to cause faulty writing to the database.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp., Mentor, OH, through SCC Soft Computer’s proprietary Task Management System on March 22, 2011.
Manufacturer: Steris Corp., Montgomery, AL. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Nationwide and Canada
