Food, drugs, devices › Mindray DS USA, Inc. dba Mindray North America
Device recall: 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-06004
Mindray DS USA, Inc. dba Mindray North America (Mahwah, NJ) initiated this device recall on 27 May 2021; FDA lists 1 product record under event 88209, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 3% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 11 Aug 2022. Initiation: voluntary: firm initiated. Mindray DS USA, Inc. dba Mindray North America has 29 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ.
Reason for recall
"Telepack may not power on when using the 3AA battery cradle."
Distribution
"Distributed US nationwide and Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2108-2021 | 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. | 804 | Class III | Terminated | 28 Jul 2021 |
Context
Other enforcement events for Mindray DS USA, Inc. dba Mindray North America
All 29 events for Mindray DS USA, Inc. dba Mindray North America
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Telepack may not power on when using the 3AA battery cradle."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed US nationwide and Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Aug 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.