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RecallWatchMedical Device Safety
Class IIOngoingZ-2279-2026

GE Medical Systems Information Technologies Inc recalls CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3

GE Medical Systems Information Technologies IncMilwaukee, WI, United StatesReported Jun 10, 2026 · 2 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product CodeSU3
    UDI-DI 00195278617644
    400 affected lots
    SU325232838SASU325032272SASU325293027SASU325222794SASU325122553SASU325363223SASU325483517SASU325152591SA
    +392 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

What the firm is doing

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.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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