CASE v7.0 Cardiac Testing System
Medical device recall Z-2279-2026. Published in FDA’s Enforcement Report on Jun 10, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 10, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1835 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
1835, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI 00195278617644 Serial numbers SU325232838SA SU325032272SA SU325293027SA SU325222794SA SU325122553SA SU325363223SA SU325483517SA SU325152591SA SU325363222SA SU325483514SA SU325272955SA SU325222809SA SU325092421SA SU325272941SA…
Every code shown here, 1,997 characters
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 SU325333170SA SU325403315SA SU325403318SA…
FDA’s list runs to 25,726 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 24, 2026.
- FDA classified it on Jun 1, 2026.
- FDA’s Enforcement Report published it on Jun 10, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems Information Technologies Inc, of Milwaukee, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 25,726 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.