| | Class 3 Recall
Reliance EPS Endoscope Processing System |  |
| Date Posted |
December 28, 2010 |
| Recall Number |
Z-0823-2011 |
| Product |
Steris Reliance EPS Endoscope Processing System , manufactured by Corporation STERIS Canada, Quebec, Canada.
Washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical endoscope devices. |
| Code Information |
Model #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 & MB000081
|
Recalling Firm/
Manufacturer |
Steris Corporation
5960 Heisley Rd
Mentor, Ohio 44060 |
Reason for
Recall |
Reliance EPS had internal water leaks and interrupted cycles when air leaks triggered false Fault 38 alarm that DG/HLD cup has not been replaced.
|
| Action |
Steris issued an "Urgent Field Correction Notice" dated July 2, 2010 to each affected US consignee, notifying them of the issue and affected device. Steris Field Service Representatives and Dealers will contact each affected customer to schedule a service visit to install system upgrades. In the event of an interrupted cycle prior to the upgrade, consignees were instructed that the load should be handled in accordance with the Reliance EPS Operators Manual. Steris can be contacted at 440-392-7043. |
| Quantity in Commerce |
936 |
| Distribution |
Worldwide distribution: USA, including states of AK, AL, AZ, CA, CO, DE, FL, ID, IL, KS, KY, MD, MI, MN, MO, NC, NV, NY, OH, PA, SC, VA, WA, WI, and WY, and countries of Algeria, Australia, Belarus, Canada, France, Germany, Greece, India, Italy, Japan, Kuwait, Lebanon, New Zealand, Russian Federation, Saudia Arabia, Spain, Turkey, United Arab Emirates and United Kingdom. |
| |
|
|
|
|
