FDA Device recall Z-0414-2016
GE Healthcare Optima IGS 320
- FDA Device
- Class II
- terminated
- Published 2015-12-23
On 2015-12-23 the FDA classified a Class II recall of GE Healthcare Optima IGS 320 by Ge Medical Systems, citing GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0414-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-13 |
| Published | 2015-12-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Medical Systems |
| Distribution | US |
Product
GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
Reason
GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems.
Identifiers
| code_info | 00000116342HL7 BA4020VA03 00000127265HL7 XVV1S15019 00000124734HL5 XV124857HL4 00000121103HL6 HC1251XR03 0000010261…00000116342HL7 BA4020VA03 00000127265HL7 XVV1S15019 00000124734HL5 XV124857HL4 00000121103HL6 HC1251XR03 00000102618HL6 083016020038813 00000128170HL8 083016061894915 00000115935HL9 083016100119314 00000125802HL9 083016200031715 00000123471HL5 083016208011415 00000118232HL8 083016240028414 00000122806HL3 083016247131115 00000112586HL3 083016280008314 00000119769HL8 083016284903114 00000122805HL5 083016287138315 00000114746HL1 083016289336814 00000116996HL0 083016601010614 00000112287HL8 083016801002714 00000108901HL0 083016801024714 00000122417HL9 083016807113615 00000109262HL6 083016807511514 00000123932HL6 083016809698915 00000119571HL8 083016824740714 00000110467HL8 083016846514214 00000104227HL4 083016860037213 00000125616HL3 083016860528415 00000113585HL4 083016861004214 00000128059HL3 083016862769215 00000126960HL4 083016029472715 00000120518HL5 083016866085914 00000120528HL5 GON4260859 00000010594HL3 083016844488913 00000105944HL3 GON4144889 00000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0414-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.