FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc. dba Mindray North America: 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.
- Recall number
- Z-1280-2015
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- 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.
- Status
- Terminated
- Initiated
- 2015-01-23
- Posted
- 2015-03-16
- Terminated
- 2017-04-20
- Reason
- An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement
- Root cause
- Process control
- Action
- 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.
- Quantity
- 519 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- 6100F- PA00195 6100F- PA00197 6100F- PA00219 6100F- PA00221 6100F- PA00267 6100F- PA00269 6100F- PA00291 6100F- PA00293
- 510(k) numbers
- ["K091834"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 2221819
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28