GE Healthcare: Medical Device Recall in 2015 - (Recall #: Z-1973-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

Product Classification:

Class II

Date Initiated: May 29, 2015

Date Posted: July 8, 2015

Recall Number: Z-1973-2015

Event ID: 71508

Reason for Recall:

GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).

Status: Terminated

Product Quantity: 3

Code Information:

System ID 083016208011415 5512XR0025 5512XR0033

Distribution Pattern:

Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM.

Voluntary or Mandated:

Voluntary: Firm initiated