Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for mo
FDA device recall Z-2737-2015 · posted 2015-09-04 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Reason for recall
- The DPM 7 Monitors may display a black screen.
- Action taken
- Mindray sent an Urgent Medical Device Correction / DPM 7 Monitor letter, dated July 27, 2015, to their affected customers via certified mail and return receipt. The letter identified the problem as well as the affected product, adverse effects on patients, and corrective action. The firm will repair the potentially affected monitor at no cost to the customer. Customers are to contact their Mindray Service Representative at 1-800-288-2121 to arrange for the repair.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 13 units
- Distribution
- Distributed to the states of CT, IA, KY, MS, PA, UT and WA.
- Date initiated
- 2015-07-27
- Date posted
- 2015-09-04
- Date terminated
- 2017-05-02
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5 (K092449) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-08-30 |