GE Healthcare Innova IGS 630. Biplane Cardiovascular recall
GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems are indicated…
Why was GE Healthcare Innova IGS 630. Biplane Cardiovascular recalled?
GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems. While performing fluoroscopy on a biplane fluoroscopy unit, there is a potential for loss of the x-ray imaging function when the user changes the size of the lateral FOV (Field of View) and releases the biplane footswitch pedal simultaneously. This could lead to a system lock up requiring
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial # System ID 00000616724BU1 956389IGS630 00000618156BU4 MCMIGS630 FMI12200DUMMY2 702731ANGIO2 00000619372BU6 732828IGS30 00000618158BU0 210705CATH1 00000622076BU9 661327IGS630 00000621314BU4 904202WCL2 00000628656BU1 281MHWCL1 00000622220BU2 303839CL4 00000625357BU9 281420LAB3BP 00000626085BU5 817BGIGS630 00000628654BU6 215576IGS4 FMI12200DUMMY3 CS1340VA01 00000614683BU1 M4152252 00000618160BU6 YV1900 00000617143BU3 YV1901 00000618157BU2 YV1902 00000620495BU2 YV1903 00000624842BU1 YV1904 00000627935BU0 YV1905 00000630300BU2 YV1906 00000617142BU5 YV1950 FMI12200DUMMY4 YV1907 00000622672BU4 850060746 00000626239BU8 850060749 FMI12200DUMMY1 SA2308VA01 00000622221BU0 ZA2239VA01 00000614682BU3 34006VAS02
- Product
- GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems are indicated…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 28 (12 US, 16 OUS).
- Distribution
- Worldwide Distribution - US Nationwide in the states of CA, CO, FL, NV, NJ, PA, TX and the countries of CZECH REPUBLIC, FRANCE, JAPAN, REPUBLIC OF KOREA, SAUDI ARABIA, and TURKEY.
- Recall date
- February 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)