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 | It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems. |
| Product | GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. |
| Quantity | 199 installed in the US |
| Distribution | Nationwide distribution |
| Initiated | 2011-12-20 |
| Classified | 2012-10-22 |
| Terminated | 2013-09-18 |
| Recall number | Z-0114-2013 |
| 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-0114-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63027/
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