STERIS 4085, 5085 & 5085SRT Surgical Tables
FDA device recall Z-1941-2010 · posted 2010-06-30 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- Reason for recall
- STERIS has learned that a limited quantity of manifold assemblies were manufactured by our supplier with incorrect washers and springs in the valves of the manifold. This supplier error has the potential to cause: a) an inability to articulate/move a table section when commanded by the operator; b) two different articulations occurring when a single articulation is commanded, or c) that the table
- Action taken
- On May 14, 2010 the firm sent FCL letters to their customers notifying them of the problem. They informed their customers that a service representative will contact them to arrange correction of the unit.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FQO
- Quantity affected
- 79 units
- Distribution
- Worldwide distribution: USA, Australia, India, Korea & New Zealand
- Date initiated
- 2010-05-14
- Date posted
- 2010-06-30
- Date terminated
- 2012-02-24
- 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 |
|---|---|---|
| STERIS CMAX XLT SURGICAL TABLE (K090136) | STERIS Corporation | 2009-03-20 |