Recall Z-2108-2021 ยท MSX System, Network And Communication, Physiological Monitors
Mindray DS USA, Inc. dba Mindray North America
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.
| Date | May 27, 2021 |
| Status | Terminated |
| Reason | Telepack may not power on when using the 3AA battery cradle. |
| Root cause | Process control |
| Action | Urgent Medical Device Correction notification letters dated 5/27/21 were sent to customers. Actions to be taken by the Customer/User Please discard all 3AA battery cradles in stock that were purchased between October 1, 2020 and March 31, 2021. Shipping records indicate your facility has XX cradles affected by this recall. Continue to use the TD60 and TM80 telepacks normally with either the 2AA battery cradle (TD60 only), or rechargeable Li-ion battery pack, if previously purchased. Please complete and return the Acknowledgement and Receipt form (found on the 3rd page of this recall notice) b |
| Quantity | 804 |
| Distribution | Distributed US nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193391 | BeneVision Central Monitoring System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., May 21, 2020 |