FDA DeviceClass IINotable

FDA Recall: LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 008838739

Date: 2026-05-20
Brand: Jolife AB
Category: Medical Device
FDA Class: Class II

Description

Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).

Hazard

Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).

Remedy

153 systems

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