Terminated

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.

FDA Recall Z-1864-2021 · Posted 2021-06-15

Recalling FirmGE Healthcare, LLC

Recall StatusTerminated

Product CodeOWB

Date Initiated2021-04-19

Date Terminated2023-08-31

Product Quantity139 devices

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.

Firm 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).

Root Cause

Component change control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare · 2018-11-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.