The Recall Desk
HighFDA (Devices)·Z-0154-2016·Announced 2015-10-28

Berchtold TELETOM Equipment Management System Recall for Control Malfunction

Berchtold Corp. is recalling TELETOM Equipment Management Systems 4 and 6 series due to potential control and brake failure caused by fluid intrusion.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device in critical care settings) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Berchtold Corp. is recalling 2,129 units of the TELETOM Equipment Management System 4 and 6 series. These ceiling-mounted devices are designed for use in operating rooms, medical treatment rooms, intensive care units, and other medical facility areas requiring power, medical gases, and data-communication services.

The recall is issued because there is a potential for the controls and brakes not to work properly. This malfunction is attributed to fluid intrusion within the control switches and/or the control board assembly. The affected units were distributed worldwide, including the United States, Canada, and Germany.

Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Berchtold Corp. for instructions on how to address the defect.

The recalled product

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 servi
Manufacturer
Berchtold Corp.
Affected units
2,129

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial # W62920
  • W62920
  • W62919
  • U61431
  • V61880
  • V61879
  • V61878
  • V61877
  • V61865
  • V61864
  • V61863
  • V61862
  • V61861
  • V61860
  • V61859
  • V61858
  • V61857
  • V61856
  • V62216
  • V62636

Distribution

Distributed nationwide across the United States.