Mindray Recalls Passport V Monitors Due to Inaccurate Blood Pressure Readings
Mindray is recalling 519 Passport V Monitors because the invasive blood pressure function may provide incorrect measurements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may provide incorrect measurements, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Mindray DS USA, Inc. dba Mindray North America is recalling 519 units of the Passport V Monitor, a multiparameter patient monitor intended for intra-hospital use under the direct supervision of a licensed healthcare practitioner. The recall is due to an issue with the invasive blood pressure (IBP) function, which may provide an incorrect IBP measurement.
The affected units were distributed nationwide. The specific lot codes for the recalled units are 6100F- PA00195, 6100F- PA00197, 6100F- PA00219, 6100F- PA00221, 6100F- PA00267, 6100F- PA00269, 6100F- PA00291, and 6100F- PA00293.
Healthcare facilities should verify if they possess any of the affected units by checking the lot codes. If a unit is affected, it should be removed from service and returned to Mindray for evaluation or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 519
Distribution
Distributed nationwide across the United States.
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