Official recall notice
FDA DeviceClass IINotable
FDA Recall: CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
- Recall date
- 2026-06-10
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
1835
Product 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.