Reported Apr 7, 2021 · Terminated
Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple…
Philips North America, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Philips SureSigns VM4
- VM6 and VM8 - Product Usagepatient 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
8630638630648630658630668630688630858630864535640219614535640219715356402200145356402204153564022081453564024371453564024401453564024421 453564024441453564024461453564024481
- Lot codes and dates
- Software versionSW A.02.63
- Amount recalled
- 31773 units
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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