Recall Z-0154-2016 ยท FQO Table, Operating-Room, Ac-Powered
Berchtold Corp.
TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care units, or any area of a medical facility that requires a ceiling mounted device to supply power, medical gases, and data-communication services. TELETOM is designed to be used in rooms that have been constructed to meet National Fire Protection Association.
| Date | Sep 23, 2015 |
| Status | Terminated |
| Reason | During the use of the TELETOM Series 4 & 6 there is potential for the controls and brakes not to work properly due to fluid intrusion within the control switches and/or the control board assembly. |
| Root cause | Device Design |
| Action | Stryker sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A Stryker Representative would visit each account for product inspection. During the inspection the Stryker Representative will remove the control switches and replace them with new control switches. Customers were instructed if any malfunction prior to inspection were noticed customers should call local Technical Support immediately at 800-243-5135. |
| Quantity | 2129 units |
| Distribution | Worldwide Distribution - US (nationwide), Canada, and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.