Recall Z-0154-2016— Berchtold Corp.
Class II · Terminated
Class II FDA medical device recall by Berchtold Corp., initiated 2015-09-23, terminated 2016-11-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..
- Recalling firm
- Berchtold Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-23
- Terminated
- 2016-11-17
- Firm location
- Charleston, SC, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.