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

Recall Z-1416-2023 — SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

U.S. FDA — Device Enforcement · Netherlands · 2023-02-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1416-2023
Date of alert
2023-02-20
Country / jurisdiction
Netherlands
Risk level
Class II
Risk type
recall
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838088566
Reported risk: There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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