Steris Reliance EPS Endoscope Processing System , manufactured by Corporation STERIS Canada, Quebec, Canada. Washing and
FDA device recall Z-0823-2011 · posted 2010-12-28 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- 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 taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MLR
- Quantity affected
- 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, C
- Date initiated
- 2010-07-02
- Date posted
- 2010-12-28
- Date terminated
- 2012-09-27
- Location
- Mentor, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE RELIANCE ENDOSCOPE PROCESSING SYSTEM (K040049) | STERIS Corporation | 2004-12-17 |