Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0268-2018

September 20, 2017

Class III

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 78733
Status
Terminated
Classification
Class III
Quantity
1079
Official record key
device-enforcement:Z-0268-2018

Official wording

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.

Code information: SureSigns VSi : 863275, 863276, 863277 SureSigns VS2+ : 863278, 863279

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.