Recall Z-1199-2019
GE Healthcare, LLC · initiated March 15, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Codes / lots: Model Number 5503558; System ID Number 0850060757; Serial Number B3-16-015
Reason for recall
There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.
FDA-determined cause: Device Design
Action taken
GE Healthcare notified customers on about 03/15/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customer were informed that they can continue to use their Innova IGS 6 or Innova IGS 630 Systems but must follow the following safety instructions: 1. Do not change the size of the field of view from 30cm to 20cm or 20cm to 30cm while releasing the fluoroscopy footswitch pedal. 2. Only perform these 2 actions sequentially. 3. If the system becomes locked up, perform a reset to recover functionalities. Customers were also informed that GE Healthcare will correct all affected products at no cost and a GE Healthcare representative will contact each customer to perform the correction. After the GE representative has updated the system, please destroy previous Innova IGS 6 SW package installation media related to this system (versions prior to IGS6_2.2.1 or IGS6_3.1.1). Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Details
- Recall number
- Z-1199-2019
- Initiated
- March 15, 2019
- Product code
- IZI – System, X-Ray, Angiographic
- Quantity
- 1 device
- Distribution
- Nationwide distribution to AR, CA, CA, FL, MI, NM, NV, SC, TN, TX, VA, WA, WI. International distribution to Algeria, Belgium, China, Colombia, France, Hungary, Italy, Japan, Korea (Republic Of), Kuwait, Libya, Pakistan, Poland, Russia, Saudi Arabia, South Africa, Sudan, Turkey, Vietnam.
- Recalling firm
- GE Healthcare, LLC, Waukesha, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1200-2019 Class II | Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic…There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from… | 03/15/2019Open, Classified |
| Z-1201-2019 Class II | Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic…There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from… | 03/15/2019Open, Classified |