GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.
Reported: June 23, 2021 Initiated: April 19, 2021 #Z-1864-2021
Product Description
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.
Reason for Recall
The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 139 devices
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, GA, KY, LA, MA, MO, MS, NC, NJ, NV, NY, PA, SC, TN, TX, VA, WA, and WI. Government distribution was made and potentially military distribution was made. The countries of Algeria, Argentina, Canada, China, Dominican Republic, Finland, France, Germany, Hungary, India, Indonesia, Iran, Iraq, Italy, Japan, Korea, Kuwait, Mexico, Moldova, Morocco, Poland, Russia, Spain, Sudan, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Uzbekistan.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.. Recalled by GE Healthcare, LLC. Units affected: 139 devices.
Why was this product recalled? ▼
The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 23, 2021. Severity: Moderate. Recall number: Z-1864-2021.
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