DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 fo
FDA device recall Z-0837-2015 · posted 2014-12-19 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Reason for recall
- Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display.
- Action taken
- Mindray DS USA, Inc. sent an Urgent Field Corrective Action Letter dated 10/6/2014 to their customers via certified mail with return receipt. The letter identified the affected product, the problem, adverse effects on the patient, and corrective actions. Customers are asked to either verify that the IBP modules are not affected by following the steps provided in the "Procedures for Verifying IBP Channel Connections;" or to discontinue use of the IBP modules until a Mindray Service Representative contacts them and performs the test to verify the function of the IBP modules. Customers are to contact their local Mindray Service Representative at 1-800-288-2121 to inform them of which corrective action will be taken. Questions should be directed to Diane Arpino at 201-995-8407 or d.arpino@mindray.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 455 units
- Distribution
- Distributed to the states of AL, CA, CO, FL, GA, IA, IL, IN, LA. MA, MO, MS, MT, NC, ND, NY, OH, PA, SC, TX, VA, WA and WV.
- Date initiated
- 2014-10-06
- Date posted
- 2014-12-19
- Date terminated
- 2017-06-06
- 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 |