FDA Device recall Z-0268-2018
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility
- FDA Device
- Class III
- terminated
- Published 2017-12-27
On 2017-12-27 the FDA classified a Class III recall of Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility by Philips Electronics North America, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0268-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-09-20 |
| Published | 2017-12-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | n/a |
Product
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
Reason
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.
Identifiers
| code_info | SureSigns VSi : 863275, 863276, 863277 SureSigns VS2+ : 863278, 863279 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0268-2018%22
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