Z-2108-2021Class III

3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00...

Name: Z-2108-2021 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2021-05-27
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2021-05-27 / Terminated / root cause: manufacturing process

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of 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... on 2021-05-27. FDA classified it as Class III and gives the reason as "Telepack may not power on when using the 3AA battery cradle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2108-2021
Classification: Class III
Status: Terminated
Initiated: 2021-05-27
Posted: 2021-07-21
Terminated: 2022-08-11
Recalling firm: Datascope Corp.
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.
Product code: MSX System, Network And Communication, Physiological Monitors
Reason for recall: Telepack may not power on when using the 3AA battery cradle.
Root cause tag: manufacturing process
FDA 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) by June 30, 2021. Product and Distribution Information The 3AA cradles included with the TD60 or TM80 telepacks distributed between October 1, 2020 and March 31, 2021 may be affected by this recall. Other Information Please complete the attached Acknowledgement and Receipt Form and return in the stamped envelope provided. Contact information is provided below should you have questions. Adverse reactions or quality problems experienced with the use of this product may be reported to FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. We apologize for any inconvenience this may cause and appreciate your cooperation. Sincerely, Diane Arpino Director, Quality Operations and Regulatory Affairs Mindray DS USA, Inc. [email protected] 201.995.8407 Distributors were instructed to do the following: 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 purchased 6 cradles affected by this recall. Continue to use the TM80 telepack normally with rechargeable Li-ion battery pack, if previously purchased. Please contact each customer which you have distributed the affected 3AA battery cradles. The format for the recall notification to send to your customers is provided. We recommend that you send the notificati
Quantity in commerce: 804
Distribution: Distributed US nationwide and Canada.
Product codes and lots: Part Number 045-001699-01; Awaiting additional details

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2108-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2108-2021	Class III	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-21

Product code MSX

K193391Class IIBeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2020-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)