Recall Z-2279-2026— GE Medical Systems Information Technologies Inc
Class II · Ongoing
Class II FDA medical device recall by GE Medical Systems Information Technologies Inc, initiated 2026-04-24. It names one FDA 510(k) clearance: K231870. Product: CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3. Reason: 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..
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-04-24
- Firm location
- Milwaukee, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.