Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Ster
FDA device recall Z-1850-2014 · posted 2014-06-23 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- Reason for recall
- Potential for the welded seam in affected monitor spring arms to crack and/or break.
- Action taken
- On April 11, 2014 the firm sent Urgent Voluntary Field Correction Notices to their customers.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FSY
- Quantity affected
- 68 units
- Distribution
- Distribution to US (states: MA, NY, OH, PA & TX) and Canada.
- Date initiated
- 2014-04-04
- Date posted
- 2014-06-23
- Date terminated
- 2014-10-15
- 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 |
|---|---|---|
| SOLA 700,SOLA 500, SOLA 300 (K010724) | Drager Medizintechnik GmbH | 2001-06-07 |