SureSigns VS3 NBP — Class II medical device recall Z-1322-2019
Ongoing recall by Philips North America, LLC, reported 2019-05-22, distributed nationwide. System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above
| Recall number | Z-1322-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2019-04-19 |
| Classified | 2019-05-13 |
| Reported by FDA | 2019-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CY, DE, DO, EG, ES, FR, GB, HK, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, KR, KW, LB, LK, LU, LV, MA, MT, MX, MY, NL, NO, NZ, OM, PH, PK, PT, QA, RO, SA, SG, SI, TH, TN, TR, TW, VE, VN, ZA |
| Quantity | 12,719 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838028890 |
Product
SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Reason for recall
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
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-1322-2019. 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.