Recall archive / FDA device enforcement
CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3 — FDA record Z-2279-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 24, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
- 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.
- Classification
- Class II
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Quantity
- 1835
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2279-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI 00195278617644 Serial numbers SU325232838SA SU325032272SA SU325293027SA SU325222794SA SU325122553SA SU325363223SA SU325483517SA SU325152591SA SU325363222SA SU325483514SA SU325272955SA SU325222809SA SU325092421SA SU325272941SA SU325272944SA SU325393292SA SU325393293SA SU325393296SA SU325443415SA SU325303053SA SU325353201SA SU324512241SA SU325032260SA SU325433377SA SU325242899SA SU325242900SA SU325192689SA SU325172624SA SU325172626SA SU325172630SA SU325333173SA SU325383266SA SU324502188SA SU325112523SA SU325112524SA SU325192719SA SU325313091SA SU325403321SA SU325323101SA SU325323103SA SU324502193SA SU324502203SA SU324502209SA SU324502211SA SU325272960SA SU325272962SA SU325252906SA SU325433376SA SU325473497SA SU324502191SA SU324502204SA SU324502206SA SU324502207SA SU325293013SA SU325293014SA SU325293015SA SU325293016SA SU325383265SA SU324482168SA SU325122538SA SU325122540SA SU325192691SA SU325192692SA SU325192708SA SU324492172SA SU325172632SA SU325182669SA SU325323135SA SU325323137SA SU325503570SA SU326033668SA SU325172613SA SU325052318SA SU325373241SA SU325443399SA SU325222802SA SU325222803SA SU325222805SA SU325293025SA SU325272954SA SU324512242SA SU325132576SA SU325172612SA SU325172614SA SU325172640SA SU325172641SA SU325192693SA SU325252910SA SU325092412SA SU325333171SA SU325122543SA SU325182687SA SU325242868SA SU325242870SA SU325473487SA SU326023667SA SU325062342SA SU325473493SA SU325252909SA SU325282987SA SU325293020SA SU325473494SA SU325473495SA SU326033696SA SU326033700SA SU326033701SA SU325463458SA SU325463461SA SU324502190SA SU325042274SA SU325122539SA SU325122541SA SU325192707SA SU325192710SA SU325192711SA SU325192717SA SU325192721SA SU325293017SA SU325293018SA SU325343185SA SU325343186SA SU325493541SA SU325493543SA SU325493549SA SU325052306SA SU325222771SA SU325222777SA SU325222778SA SU325222783SA SU325222797SA SU325493536SA SU325493539SA SU325313066SA SU325313067SA SU325313068SA SU325333167SA SU325333168SA 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SU325102480SA SU325112487SA SU326033705SA SU325062326SA SU325072356SA SU325072392SA SU325313085SA SU32... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
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, 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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 10, 2026
- Recall initiation date
- Apr 24, 2026
- Center classification date
- Jun 1, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.