FDA Device recall Z-1280-2015
Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct s…
- FDA Device
- Class II
- terminated
- Published 2015-03-25
On 2015-03-25 the FDA classified a Class II recall of Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct s… by Mindray Ds Usa, citing an issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1280-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-23 |
| Published | 2015-03-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mindray Ds Usa |
| Distribution | US |
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.
Reason
An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement
Identifiers
| code_info | 6100F- PA00195 6100F- PA00197 6100F- PA00219 6100F- PA00221 6100F- PA00267 6100F- PA00269 6100F- PA00291 6100F- PA00293 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1280-2015%22
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