FDA-Device2015-10-28Class II
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.
Berchtold Corp.
Hazard
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.
Sold states
Worldwide Distribution - US (nationwide), Canada, and Germany
Affected count
2129 units
Manufactured in
1950 Hanahan Rd, N/A, Charleston, SC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0154-2016Don't want to check this manually?
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