Recall Z-1864-2021 ยท OWB Interventional Fluoroscopic X-Ray System
GE Healthcare, LLC
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.
| Date | Jun 15, 2021 (initiated Apr 19, 2021) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component change control |
| Action | The recalling firm issued letters dated 4/19/2021 via traceable mail on 4/20/21 and issued an additional letter dated 4/28/2021 to correct an omission of serial numbers (only sent to the affected consignees). |
| Quantity | 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 Re |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181403 | Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR GE Healthcare, Nov 2, 2018 |