CASE v7 — Class II medical device recall Z-2279-2026
Ongoing recall by GE Medical Systems Information Technologies Inc, reported 2026-06-10, distributed nationwide. Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes
| Recall number | Z-2279-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems Information Technologies Inc, Milwaukee, WI, United States |
| Recall initiated | 2026-04-24 |
| Classified | 2026-06-01 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BD, CA, DE, DK, DZ, ES, FI, FR, GB, GR, HK, HR, ID, IE, IN, IT, JP, KR, LB, LK, LT, MY, NL, NO, NZ, PH, PL, QA, RO, SA, SE, SG, TH, TN, TR, TW, ZA |
| Quantity | 1,835 |
| UPC / GTIN / UDI-DI | 00195278617644 |
| Serial numbers | SU323110003SA, SU323121000SA, SU323121001SA, SU323461002SA, SU323461003SA, SU323462000SA, SU323462002SA, SU323462003SA, SU323462004SA, SU323481007SA, SU323481008SA, SU323481009SA, SU323481010SA, SU323482005SA, SU323482006SA, SU323482007SA, SU323482008SA, SU323482009SA, SU323482010SA, SU323482011SA, SU323511013SA, SU323511014SA, SU323511015SA, SU323512015SA, SU323512016SA and 475 more |
| Model numbers | 3031234-001 |
Product
CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2279-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.