Z-0268-2018Class III

Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport...

Name: Z-0268-2018 Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport...
Creator: Philips Electronics North America Corporation
Published: 2017-09-20
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-09-20 / Terminated / root cause: labeling and UDI

FDA source

Philips Electronics North America Corporation began a recall of Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility on 2017-09-20. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0268-2018
Classification: Class III
Status: Terminated
Initiated: 2017-09-20
Posted: 2017-12-20
Terminated: 2020-04-17
Recalling firm: Philips North America LLC
Product: Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Philips sent each known affected customer a Field Safety Notice, dated September, 2017. The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips will provide a corrected label free of charge
Quantity in commerce: 1079
Distribution: Worldwide distribution. Australia, Austria, Bahrain, Belgium, Brazil, Denmark, France, French Polynesia, Germany, Hong Kong, India, Ireland, Israel, Italy, Kenya, Lebanon, Lesotho, Malaysia, Maldives, Morocco, Netherlands, Oman, Pakistan, Palestine, Poland, Saudi Arabia, South Africa, Spain, Sweden, Thailand, Turkey, United Kingdom, UAE, Vietnam, and Zimbabwe.
Product codes and lots: SureSigns VSi : 863275, 863276, 863277 SureSigns VS2+ : 863278, 863279

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0268-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0268-2018	Class III	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-20

Product code MHX

K112652Class IISuresigns Vs2+ -Suresigns VsiPhilips Medical Systems / cleared 2011-10-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)