Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable leave an area potentially unprotected. |
| Product | GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy. |
| Quantity | 48 |
| Distribution | Worldwide Distribution-USA including the states of FL, IL, IN, NJ, NC, OK, TX, and WI, and the countries of UNITED KINGDOM, TUNISIA, SERBIA, RUSSIAN FEDERATION, NORWAY, NIGERIA, LITHUANIA, LEBANON, KOREA, REPUBLIC OF KOREA, ITALY, INDONESIA, INDIA, FRANCE, FINLAND, COLOMBIA, CHINA, and BRAZIL. |
| Initiated | 2011-02-04 |
| Classified | 2013-03-11 |
| Terminated | 2014-01-27 |
| Recall number | Z-0934-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-0934-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64274/
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