FDA recall, , Moderate risk
CASE v7.0 Cardiac Testing System
The CASE v7.0 Cardiac Testing System can spark at the printer head, potentially causing serious thermal injury.
Summary by Recall Canary from the FDA notice
What happened
GE Medical Systems Information Technologies Inc of Milwaukee, Wisconsin began a recall of the CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3 on April 24, 2026. The recall was added to the FDA's Enforcement Report on June 1, 2026.
Electrical sparking may occur at the printer head if the Electrostatic Discharge (ESD) printer brush becomes dislodged, which can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury. The product was distributed worldwide, including the US Nationwide and numerous other countries.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI or model number is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
- UDI-DI
- 00195278617644
- Recall number
- Z-2279-2026
- Model number
- 3031234-001
Recall details
- Company began the recall
- Sold in
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.
- Company
- GE Medical Systems Information Technologies IncMilwaukee, Wisconsin
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98932
- Recall number
- Z-2279-2026
All recalls from GE Medical Systems Information Technologies Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
