Recall Z-1864-2021— GE Healthcare, LLC

Name: FDA recall Z-1864-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-19

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-04-19, terminated 2023-08-31. It names one FDA 510(k) clearance: K181403. Product: 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: 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2021-04-19
Terminated: 2023-08-31
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K181403 — Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare·cleared 2018-11-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.