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.
What this means for you
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.
Related recalls
Same manufacturer · Mindray DS USA, Inc. dba Mindray North America
See all →- HighCentral monitoring workstations recalled over audio failure and screen freezing
FDA (Devices) · 2025-12-24
- HighAnesthesia vaporizers recalled over the potential for anesthesia leakage
FDA (Devices) · 2025-12-03
- HighIsoflurane vaporizers recalled over the potential for anesthesia leakage
FDA (Devices) · 2025-12-03
- HighPatient monitors recalled over potential activation of an abnormal alarm pause
FDA (Devices) · 2025-10-01
- HighSevoflurane Vaporizer for A9 Anesthesia System Recalled for Output Malfunction
FDA (Devices) · 2024-09-11
Same hazard · inaccurate measurement
See all →- ModerateFujifilm Synapse PACS Software Recalled for Inaccurate Ruler Measurements
FDA (Devices) · 2026-09-02
- HighMerge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements
FDA (Devices) · 2026-09-02
- High3mensio Workstation Software Recalled Due to Inaccurate Cardiovascular Measurements
FDA (Devices) · 2026-07-29
- HighOral thermometer probes recalled after being programmed with rectal configuration
FDA (Devices) · 2025-10-29
- HighUltrasound systems recalled over inaccurate liver steatosis measurement values
FDA (Devices) · 2025-10-22