Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
Reported: March 25, 2015 Initiated: January 23, 2015 #Z-1280-2015
Product Description
Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
Reason for Recall
An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement
Details
- Recalling Firm
- Mindray DS USA, Inc. dba Mindray North America
- Units Affected
- 519 units
- Distribution
- Nationwide Distribution
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.. Recalled by Mindray DS USA, Inc. dba Mindray North America. Units affected: 519 units.
Why was this product recalled? ▼
An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2015. Severity: Moderate. Recall number: Z-1280-2015.
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