DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Inten
FDA device recall Z-0513-2013 · posted 2012-12-11 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Reason for recall
- There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations.
- Action taken
- Mindray sent a "PRODUCT CORRECTIVE ACTION" letter dated August 11, 2010 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact their Mindray Service Representative at 1-800-288-2121 for assistance with this issue.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 124 units
- Distribution
- Nationwide Distribution-USA (nationwide) including the states of WA, IL, FL, MN, SC, NV, MI, TN, PA, LA, NE, TX, and IA.
- Date initiated
- 2010-08-11
- Date posted
- 2012-12-11
- Date terminated
- 2013-08-02
- Location
- Mahwah, NJ
Monitor recalls programmatically
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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 |