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

Recall Z-2027-2023 — TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter

U.S. FDA — Device Enforcement · Finland · 2023-05-19 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2027-2023
Date of alert
2023-05-19
Country / jurisdiction
Finland
Risk level
Class I
Risk type
recall
Brand
GE Healthcare Finland Oy
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0840682103176
Reported risk: There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
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.

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