Philips North America, LLC recalls SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, S…
- Recall date
- April 19, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1324-2019
- FDA classification
- Class II
- Brand / firm
- Philips North America, LLC
- Sold / distributed
- Worldwide distribution. US Nationwide including Puerto Rico, Andorra, Argentina, Aruba, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Dominican Republic, Egypt, France, French Guiana, French Polynesia, Germany, Gibraltar…
Why it was recalled
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
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