CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
FDA Recall Z-2279-2026 · Posted 2026-06-01
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Recalling FirmGE Medical Systems Information Technologies Inc
Recall StatusOpen, Classified
Product CodeDQK
Date Initiated2026-04-24
Product Quantity1835
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
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, Norway, Philippines, Poland, Qatar, Romania, Saudi Arabia, Senegal, Singapore, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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