GE Healthcare: Medical Device Recall in 2015 - (Recall #: Z-1981-2015)

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 Innova IGS 530. 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-1981-2015

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: 17

Code Information:

Serial Number System ID Not Available 702731CATH3 0000013C2R0003 6012883100CV4 15C2R0084 702880CATH2 15C2R0086 GON4300165 15C2R0085 918787530 15C2R0087 814877EP 0000015C2R0091 GON1441141 0000014C2R0188 XV650620BU8 0000015C2R0083 GON1487269 0000015C2R0088 GON4271086 0000015C2R0064 080041RX18 15C2R0055 414649IGS2 15C2R0072 GON4211904 0000015C2R0074 0004077351 0000015C2R0066 082416190029 0000015C2R0070 082416100092 0000015C2R0071 082416190026

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