Recall Z-1640-2010 ยท FSY Light, Surgical, Ceiling Mounted
Stryker Communications Corp
Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light), Catalog numbers: 0682001250, 0682001251. Intended to illuminate the operative site during surgical procedures with high intensity light.
| Date | May 21, 2010 (initiated Apr 15, 2010) |
| Status | Terminated |
| Reason | Installation records are incomplete. |
| Root cause | Employee error |
| Action | An Urgent: Medical Device Product Correction customer notification letter, dated 4/15/2010, has been sent out to all affected accounts via regular mail in the form of a certified, return request receipt letter. Accounts will receive a follow-up phone call from a Stryker Representative to schedule a re-inspection of equipment to see if it mets established critical specifications or not. The firm recommends that customers continue using all Stryker Communications products listed in the notice. Questions can be directed to Katie Blackwell at 972-410-7660 or via email at StrykerCommunicationsRA |
| Quantity | 608 (all lights and booms) |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |