GE Healthcare: GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical

Is my product affected?

GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

• UPC 082416190029
• UPC 082416100092
• UPC 082416190026

Check against the official notice below — it lists the full affected range.

What happened

GE Healthcare has recalled 17 GE Healthcare Innova IGS 530 angiographic X-ray systems due to a potential safety issue that may 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 systems have been distributed worldwide, including across multiple U.S. states and countries such as Canada, the United Kingdom, Japan, China, and Brazil.

The recall involves 17 specific units identified by their serial numbers and lot codes. However, the source document does not specify what remedy consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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).

Details from the source

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: 17 Lot/code info: Serial Number System ID Not Available 702731CATH3 0000013C2R0003 6012883100CV4 15C2R0084 702880CATH2 15C2R0086 GON4300165 15C2R0085 918787530 15C2R0087 814877EP 0000015C2R0091 GON1441141 0000014C2R0188 XV650620BU8 0000015C2R0083 GON1487269 0000015C2R0088 GON4271086 0000015C2R0064 080041RX18 15C2R0055 414649IGS2 15C2R0072 GON4211904 0000015C2R0074 0004077351 0000015C2R0066 082416190029 0000015C2R0070 082416100092 0000015C2R0071 082416190026

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It2015-05-29
• GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.2015-05-29
• 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.2015-05-29
• GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.2015-05-29
• GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.2015-05-29

All FDA (Device enforcement) recalls