Mindray DS USA, Inc. dba Mindray North America: Medical Device Recall in 2015 - (Recall #: Z-1280-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 23, 2015

Date Posted: March 25, 2015

Recall Number: Z-1280-2015

Event ID: 70546

Reason for Recall:

An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement

Status: Terminated

Product Quantity: 519 units

Code Information:

6100F- PA00195 6100F- PA00197 6100F- PA00219 6100F- PA00221 6100F- PA00267 6100F- PA00269 6100F- PA00291 6100F- PA00293

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated