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

Recall Z-1318-2019 — SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

U.S. FDA — Device Enforcement · United States · 2019-04-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1318-2019
Date of alert: 2019-04-19
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): 00884838028890

Reported risk: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

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.

Recall Z-1318-2019 — SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

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