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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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.
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