GE Healthcare, LLC: Medical Device Recall in 2019 - (Recall #: Z-1199-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 15, 2019

Date Posted: April 24, 2019

Recall Number: Z-1199-2019

Event ID: 82514

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.

Status: Ongoing

Product Quantity: 1 device

Code Information:

Model Number 5503558; System ID Number 0850060757; Serial Number B3-16-015

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated