GE Healthcare — Class II medical device recall Z-1163-2014
Terminated recall by GE Healthcare, LLC, reported 2014-03-19, distributed nationwide. GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can
| Recall number | Z-1163-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-12-11 |
| Classified | 2014-03-10 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2014-07-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CN, CZ, DE, DK, EG, ES, FI, FR, GB, HU, IE, IN, IT, JO, JP, KR, LK, MX, MY, NO, NZ, PH, PL, RU, SA, TR |
| UPC / GTIN / UDI-DI | 00082416310003 |
Product
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention angiography procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology. This device is not intended for mammography applications. The Innova 3100 system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, and optionally, rotational and angiography procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications. A new tilt table will support performing procedures like CO2 studies, Venography. The Digital Fluoroscopic Imaging System with Bolus Chasing option is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention; the option Bolus enables to perform subtraction angiography of lower limbs. This device is not intended for mammography applications. The Innova 2100-IQ system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures, and optionally, rotational angiography procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology diagnostic and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. This device is not intended for mammography applications. For Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100 IQ, Innova 2100IQ with Innova 3T Option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova CT is a software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. Innova CT is intended for imaging bone and soft tissues as well as other internal body structures. Innova CT is not intended for mammography applications. For Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100 IQ, Innova 2100IQ with Innova 3D or InnovaSpin option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. It is not intended for mammography applications. InnovaSpin is a software option that permits fast spin rotational angiography. It is not intended for mammography applications. :
Reason for recall
GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. No injuries have been reported due to this issue.
Machine access
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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.