Recall Z-2279-2026 ยท DQK Computer, Diagnostic, Programmable
GE Medical Systems Information Technologies Inc
CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
| Date | Jun 1, 2026 (initiated Apr 24, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 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, Italy, Japan, South Korea, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System Ge Medical Systems Information Technologies, Inc., Dec 13, 2023 |