RecallRadar

FDA Device recall Z-0268-2018

Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility

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

AgencyFDA Device
Recall numberZ-0268-2018
ClassificationClass III
Statusterminated
Initiated2017-09-20
Published2017-12-27
Last updated2026-09-13 11:54 UTC
CompanyPhilips Electronics North America
Distributionn/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_infoSureSigns 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.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0268-2018%22

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