Z-0554-2018Class II

TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00

Name: Z-0554-2018 TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2017-07-14
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2017-07-14 / Terminated / root cause: design

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00 on 2017-07-14. FDA classified it as Class II and gives the reason as "A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0554-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-14
Posted: 2018-02-08
Terminated: 2018-12-17
Recalling firm: Datascope Corp.
Product: TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
Product code: MSX System, Network And Communication, Physiological Monitors
Reason for recall: A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate.
Root cause tag: design
FDA root cause: Component design/selection
Action: Certified letters were sent to all affected customers on 07/14/2017, to offer a replacement of the battery charger.
Quantity in commerce: 203
Distribution: Distributed in 26 states: AL, CA, CO, FL, GA, IA, IN, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, SD, TX, UT, WA, and WY; and Puerto Rico.
Product codes and lots: All battery chargers with part number 115-030108-00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0554-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0554-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-08

Product code MSX

K150632Class IIHypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2015-07-06

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)