CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
FDA device recall Z-2279-2026 · posted 2026-06-01 · Open, Classified
Recall details
- Recalling firm
- GE Medical Systems Information Technologies Inc
- 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.
- Action taken
- Firm notified consignees starting on April 24, 2026 via letters titled "URGENT MEDICAL DEVICE CORRECTION." Pending corrections from GE Healthcare, customers were instructed to perform a visual inspection of the printer assembly to verify proper positioning of the ESD brush. Customers may continue to use the device if the brush is properly positioned and aligned. However, if the brush appears misaligned or displaced, stop using the device and contact a GE HealthCare Service representative.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DQK
- Quantity affected
- 1835
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Bangladesh, Cambodia, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland,
- Date initiated
- 2026-04-24
- Date posted
- 2026-06-01
- Location
- Milwaukee, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System (K231870) | Ge Medical Systems Information Technologies, Inc. | 2023-12-13 |