FDA-Device2017-12-27Class III

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

Philips Electronics North America Corporation
Hazard

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.

Sold states
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.
Affected count
1079
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0268-2018

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