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Recall Observatory FDA recall evidence

Device 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.

Z-2108-2021

May 27, 2021

Class III

Product summary

Firm
Mindray DS USA, Inc. dba Mindray North America
Event
Event 88209
Status
Terminated
Classification
Class III
Quantity
804
Official record key
device-enforcement:Z-2108-2021

Official wording

Reason: Telepack may not power on when using the 3AA battery cradle.

Code information: Part Number 045-001699-01; Awaiting additional details

Distribution pattern: Distributed US nationwide and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Telepack may not power on when using the 3AA battery cradle.