FDA-Device2021-07-28Class III
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.
Mindray DS USA, Inc. dba Mindray North America
Hazard
Telepack may not power on when using the 3AA battery cradle.
Sold states
Distributed US nationwide and Canada.
Affected count
804
Manufactured in
800 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2108-2021Don't want to check this manually?
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