# FDA recall Z-1199-2019

> **GE Healthcare, LLC** · Class II · device recall initiated 2019-03-15.

## Product

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.

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-1199-2019
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-03-15
- **Report date:** 2019-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1199-2019

## Citation

> AI Analytics. FDA recall Z-1199-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1199-2019. Source: US FDA. Licensed CC0.

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