Recall – Patient monitor range/accuracy incorrect

Company: Philips North America, LLC
Date of Enforcement Report: 4/7/2021
Class II


Philips SureSigns VM4, VM6 and VM8 – Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi”gns VM8 (863066, 863068, 863087, 863088) Model Numbers: 863063,863064,863065,863066,863068,863085,863086, 453564021961,453564021971, 53564022001,453564022041, 53564022081,453564024371, 453564024401,453564024421 453564024441,453564024461, 453564024481

Recall Number: Z-1326-2021


Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and Range/accuracy of heart rate meter for pediatric mode-In pediatric mode, when the input signal rate is over 300 bpm, the indicated rate of the affected products will be lower than this upper limit.


Philips North America, LLC on 3/23/2021. Voluntary:  Firm Initiated recall is ongoing.


31773 units



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