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U.S. Department of Health and Human Services

Class 2 Device Recall Innova IGS 630, Angiographic XRay, s5i system option

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  Class 2 Device Recall Innova IGS 630, Angiographic XRay, s5i system option see related information
Date Initiated by Firm March 15, 2019
Create Date April 18, 2019
Recall Status1 Open3, Classified
Recall Number Z-1199-2019
Recall Event ID 82514
510(K)Number K111209  
Product Classification System, x-ray, angiographic - Product Code IZI
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.
Code Information Model Number 5503558; System ID Number 0850060757; Serial Number B3-16-015
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer 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 2		 Device Design
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IZI and Original Applicant = GE HEALTHCARE
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