Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1326-2021 — 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) Sur

U.S. FDA — Device Enforcement · United States · 2021-03-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1326-2021
Date of alert: 2021-03-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips North America, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 453564021961

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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