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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 121 03 14 000
Date submitted: 3/26/2014
Manufacturer:GE Healthcare
Device Type:Innova 2100IQ, Innova 2121IQ, Innova 3100, Innova 3100IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova IGS 620, Innova IGS 630 Cardiovascular X-ray imaging systems
Description: X-ray imaging systems.
Medical Device Identifier:Please find attached list of affected products.
Reason of Field Safety Corrective Action:The Innova system may not boot up properly after a power-on or after a system reset. Additionally it may shut down unexpectedly during an exam which may result in the total loss of real-time interventional imaging. No injuries have been reported due to this issue.
Remedy Action:Before each use, please ensure the Innova system emits X-rays and is in working condition. Perform a quick system functional check by creating a test patient on the system console and verify that fluoroscopy/record acquisitions are available. If your system does not boot up, then reset the system. If the problem persists, contact your local GE Healthcare Service Representative. GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call the following phone numbers, Saudi Arabia Toll Free number: 8001243002.
Athorized Representative/Importer/Distributor:GE Healthcare, (011) 4600530
Report Source:NCMDR
Source Ref. Number:62E9192C531E3
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare.pdf