Passport V Monitor — Class II medical device recall Z-1280-2015
Terminated recall by Mindray DS USA, Inc. dba Mindray North America, reported 2015-03-25, distributed nationwide. An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide
| Recall number | Z-1280-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2015-01-23 |
| Classified | 2015-03-16 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2017-04-20 |
| Distributed | Nationwide (US) |
| Quantity | 519 units |
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 for recall
An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1280-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.