Recall Z-1886-2011 ยท FSY Light, Surgical, Ceiling Mounted
Steris Corporation
Harmony LA/LED Monitor Arm Adapter. Model Number: LB61 The Harmony LA/LED Monitor Arm Adapter is an accessory to the Harmony LA and LED Surgical Lighting System and is attached to the end of the monitor suspension arm to allow Customers to attach other medical devices, such as non-STERIS monitors, camera or other compatible items in place of the STERIS monitor. The Harmony Surgical Lighting and M
| Date | Apr 5, 2011 (initiated Feb 18, 2011) |
| Status | Terminated |
| Reason | The arm adapter does not contain labelling specifying the applicable weight and moment limitations of the arm adapter |
| Root cause | Other |
| Action | Steris Corporation sent an Urgent Field Correction Notice letter dated February 18, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A Steris representative would contact customers to arrange for replacement of the product. For questions regarding the firms visit to their facility, customers were instructed to contact Steris Field Service Dispatch at 1-800-333-8828. For any questions regarding this matter call 440-392-7705. |
| Quantity | 14 Units |
| Distribution | Worldwide Distribution - USA including CO, IL, IN, MO, NC, NV, NY and OH and the countrries of Canada, China, and Australia. |
| FDA record | Open on fda.gov |