GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Check against the official notice below — it lists the full affected range.
GE Healthcare has issued a recall for six Innova 3100IQ angiographic X-ray systems, along with Optima and Discovery models, due to a potential safety issue that could cause loss of C-arm gantry motion capability on fluoroscopic interventional imaging systems. These systems are used to generate fluoroscopic and rotational images of human anatomy for diagnostic, interventional, and image-guided surgical purposes. The affected devices have been distributed worldwide, including throughout the United States and in multiple countries including Canada, China, Japan, the United Kingdom, and others.
The record does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
Reason for recall: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). Distribution: Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM. Quantity: 6 Lot/code info: Serial Number System ID 0000010C2M037O 620272INNOVA31 0000009C2M0192 X98766705 00000464106BU4 A5127281 00000007C20175 RU2741VA01 0000013C2S0087 082416100052 0000010C2M0299 082416100030
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.