Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use
FDA device recall Z-1280-2015 · posted 2015-03-16 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Reason for recall
- An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement
- Action taken
- Mindray DS USA Inc sent Urgent: Passport V Monitor Field Corrective Action letters dated 1/23/2015 to hospital administrators. The letters informed customers that the IBP module may provide an incorrect IBP measurement. The letter also explained the adverse effects on patients. Customers are asked to either calibrate the IBP following the instructions provided; or, contact a Mindray Service Representative, who can perform the calibration, at 1-800-288-2121. In the case of the second option, it is recommended that the monitor be removed from service until the calibration is performed. If the first option is chosen, customers are to notify a Service Representative upon completion of the action. Customers can direct their questions to Diane Arpino at 201-995-8407.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 519 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-01-23
- Date posted
- 2015-03-16
- Date terminated
- 2017-04-20
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PASSPORT V MONITOR, MODEL 0998-00-6100 (K091834) | Datascope Corp., Patient Monitoring Division | 2009-07-15 |