[pending] CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
Pending LLM rewrite. Source: FDA_DEVICE Z-2279-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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