FDA DeviceClass IINotable

FDA Recall: CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3

Date: 2026-06-10
Brand: GE Medical Systems Information Technologies Inc
Category: Medical Device
FDA Class: Class II

Description

Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury.

Hazard

Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury.

Remedy

1835

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