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FDAFDA · Food and drugs·Recall number Z-0268-2018

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

Published December 27, 2017 · Recall initiated: September 20, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the 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.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Philips Electronics North America Corporation
Distributor
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.
Lot
SureSigns VSi : 863275, 863276, 863277 SureSigns VS2+ : 863278, 863279
Risk classification
Class III
Area (FDA)
device
Country
United States

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