Recall Z-0554-2018— Mindray DS USA, Inc. dba Mindray North America
Class II · Terminated
Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2017-07-14, terminated 2018-12-17. It names one FDA 510(k) clearance: K150632. Product: TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00. Reason: A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate..
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-14
- Terminated
- 2018-12-17
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.