Recall Record: Class II Recall: CASE v7.0 Cardiac Testing System Model no. 3031234-001… by GE Medical Systems Information Technologies Inc

Key facts

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3 -- and the recall number Z-2279-2026. If it matches, stop using or distributing it and contact GE Medical Systems Information Technologies Inc or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is GE Medical Systems Information Technologies Inc and the affected product is described in FDA's record as: CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3. FDA's stated reason for the recall is: 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.. The recall is tracked under FDA recall number Z-2279-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

GE Medical Systems Information Technologies Inc’s FDA history

Argus HQ has recorded 7 total FDA actions tied to GE Medical Systems Information Technologies Inc: 0 warning letters, 7 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the FDA recall number for this event?

FDA recall number Z-2279-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What was recalled and why?

GE Medical Systems Information Technologies Inc recalled CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3. FDA's record states the reason for recall as: 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.. The recall is logged under FDA recall number Z-2279-2026 with a Class II classification.

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