Medical device recalls

Philips Electronics North America Corporation recalls Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facil…

Recall date
September 20, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0268-2018
FDA classification
Class III
Brand / firm
Philips Electronics North America Corporation
Sold / distributed
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…

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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

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