Recall Z-1850-2014 ยท FSY Light, Surgical, Ceiling Mounted
Steris Corporation
Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262.
| Date | Jun 23, 2014 (initiated Apr 4, 2014) |
| Status | Terminated |
| Reason | Potential for the welded seam in affected monitor spring arms to crack and/or break. |
| Root cause | Device Design |
| Action | On April 11, 2014 the firm sent Urgent Voluntary Field Correction Notices to their customers. |
| Quantity | 68 units |
| Distribution | Distribution to US (states: MA, NY, OH, PA & TX) and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010724 | SOLA 700,SOLA 500, SOLA 300 Drager Medizintechnik GmbH, Jun 7, 2001 |