Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in… — Class III medical device recall Z-0268-2018
Terminated recall by Philips Electronics North America Corporation, reported 2017-12-27. Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead of
| Recall number | Z-0268-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2017-09-20 |
| Classified | 2017-12-20 |
| Reported by FDA | 2017-12-27 |
| Terminated | 2020-04-17 |
| Countries outside the US | AE, AT, AU, BE, BH, BR, DE, DK, ES, FR, GB, HK, IE, IL, IN, IT, KE, LB, MA, MY, NL, OM, PK, PL, SA, SE, TH, TR, VN, ZA |
| Quantity | 1,079 |
| Reason classes | labeling |
Product
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
Reason for recall
Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead of the specific date in the format of YYYY-MM.
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-0268-2018. 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.