Medical device recalls Moderate risk

Berchtold product recalled over fire hazard

Recall date
September 23, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Berchtold Corp. recalls TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment ro…
Recall number
Z-0154-2016
FDA classification
Class II
Brand / firm
Berchtold Corp.
Sold / distributed
Worldwide Distribution - US (nationwide), Canada, and Germany

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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