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FDA DevicesClass II

CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3

Publié le: 10 juin 2026ID du rappel: Z-2279-2026Catégorie: Dispositifs MédicauxPays: États-Unis
US
Medical DeviceFDA DevicesUSUS

CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3

Recalling Firm: GE Medical Systems Information Technologies Inc

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Traduire l’alerteTranslate notice text, hazard warnings, and descriptions into any supported language.

Motif du rappel / Danger

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.

Description du produit & Identification

CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3

Produits concernés

CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3

Additional Source Details

FieldValue
CityMilwaukee
StateWI
Event id98932
Address 19900 W Innovation Dr
Code infoUDI-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 SU325323137... [TRUNCATED]
Postal code53226-4856
Report date20260610
Product typeDevices
Product quantity1835
Reason for recallElectrical 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.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260424
Initial firm notificationLetter
Center classification date20260601

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Aperçu

  • Entreprise responsableGE Medical Systems Information Technologies Inc
  • StatusOngoing
  • Niveau de risqueClass II
  • DistributionWorldwide 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.
Recall Hazard Severity
High Alert (Class I)
Alerte officielle de l’agence

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

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https://therecallfile.com/fr/recalls/case-v7-0-cardiac-testing-system-model-no-3031234-001-product-code-su3/FDA-Z-2279-2026
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