07

Apr

2021

Recall – Patient monitor range/accuracy incorrect

recall, softwareerror

0

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

PRODUCT

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

REASON

Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. 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.

RECALLING FIRM/MANUFACTURER

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

VOLUME OF PRODUCT IN COMMERCE

31773 units

DISTRIBUTION

International

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