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Terminated

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.

FDA Recall Z-0154-2016 · Posted None

Recalling FirmBerchtold Corp.
Recall StatusTerminated
Product CodeFQO
Date Initiated2015-09-23
Date Terminated2016-11-17
Product Quantity2129 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US (nationwide), Canada, and Germany

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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