The Recall Desk
ModerateFDA (Devices)·Z-2108-2021·Announced 2021-07-28

Mindray battery cradle may prevent monitor from powering on

Mindray is recalling the 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 and TM80 Telepack physiological monitors. The cradle may prevent the monitor from powering on. Approximately 804 units were distributed in the US and Canada.

What this means for you

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: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is a functional failure (device may not power on) of a physiological monitoring device. Class III recalls without reported adverse events warrant a Moderate severity score.

Plain-English summary

Mindray DS USA, Inc. is recalling the 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack and TM80 Telepack physiological data monitors. The recalled battery cradle may prevent these monitors from powering on.

Approximately 804 units of the battery cradle were distributed nationwide in the United States and Canada. If the battery cradle fails to deliver sufficient power, the monitor may not turn on, potentially disrupting patient monitoring capabilities.

Consumers who have this battery cradle should contact Mindray DS USA, Inc. for a replacement or alternative power solution. For assistance or to report issues with this battery cradle or Telepack monitors, customers should reach out to Mindray DS USA, Inc. directly.

The recalled product

Product
3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.
Manufacturer
Mindray DS USA, Inc. dba Mindray North America
Hazard
  • power-failure

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 (2)

  • Part Number 045-001699-01
  • Awaiting additional details

Distribution

Distributed nationwide across the United States.