Mindray TD60 Display Telemetry Transmitter Recalled for Bezel Cracking and Power Issues
Mindray is recalling 1,278 TD60 Display Telemetry Transmitters because the bezel may crack or the device may fail to power on.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes functional defects (cracking bezel, power failure) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Mindray DS USA, Inc. dba Mindray North America is recalling 1,278 units of the TD60 Display Telemetry Transmitter. The affected devices are used with the BeneVision Central Station and were distributed in the US and Canada.
The recall was initiated because the bezel surrounding the display may crack. Additionally, the transmitter may not power on, or it may power on but display an error message. The specific serial numbers affected are listed in the official recall notice.
Healthcare facilities and users should stop using the affected TD60 Display Telemetry Transmitters and contact Mindray for further instructions on repair or replacement.
The recalled product
- Product
- TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Affected units
- 1,278
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)
- p/n 115-029485-00
- Serial #'s HHA59001430
- HHA59001439
- HHA59001450 thru HHA59001460
- HHA59001537
- HHA59001540
- HHA59001549 thru HHA59001550
- HHA59001591
- HHA59001609
- HHA59001615
- HHA59001626
- HHA59001632
- HHA5A003110
- HHA5A003113 thru HHA5A003115
- HHA5A003118 thru HHA5A003119
- HHA5C004233
- HHA5C004485
- HHA59001420 thru HHA59001429
- HHA5B003441 thru HHA5B003450
- HHA5C004059
Distribution
Distribution scope not specified by the agency.
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