Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
Check against the official notice below — it lists the full affected range.
GE Medical Systems is recalling 102 Innova IGS interventional fluoroscopic X-ray systems (models 630, 520, and 530) distributed across multiple U.S. states and international locations. These systems may experience X-ray abort errors that could result in loss of imaging mode before or during fluoroscopic use.
The affected devices are identified by specific lot numbers and system IDs across the three model variants. The record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
Reason for recall: The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use. Distribution: US distribution: AR, CA, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, A,WI, WV. International Distribution: Argentina, Brazil, China, Colombia, Egypt, France, India, Indonesia, Iran, Italy, Japan, Kuwait, Lithuania, Myanmar, Palestine, Poland, Russia, Saudi Arabia, Singapore, Spain, Tunisia, Turkey, United Kingdom, Vietnam. Quantity: 102 devices total Lot/code info: a. Innova IGS 630, Model Number 5730860 - Lot Number (System ID): 00000B3-18-001 (401BIPLANE1), 00000B3-17-032 (505841CATH3), 00000B3-17-029 (956632IGS630), 00000B3-17-030 (YV4502), 00000B3-18-002 (941629IGS630), 00000B3-17-031 (082416160071), 00000B3-18-003 (GON 4601349); b. Innova IGS 520, Model Number 5731194 - Lot Number (System ID): 00000M2-18-008 (410337CATH3), 00000M2-17-090 (603663DIGS), 00000M2-17-088 (603433IGS520), 00000M2-18-004 (423493CATH1), 00000M2-18-002 (414649IGS5), 00000M2-18-003 (414649IGS6), 00000M2-17-087 (M2505310), 00000M2-18-009 (00197VAS02), 00000M2-17-091 (082416040075), 00000M2-18-012 (GON 4607591), 00000M2-18-007 (GON 4607578), 00000M2-18-010 (GON 4607585), 00000M2-18-018 (GON 4592554), 00000M2-17-089 (083016866794118), 00000M2-18-001 (083016865380618), 00000M2-18-005 (GON 4608047), 00000M2-18-019 (GON 4596530), 00000M2-18-013 (GON 4610633), 00000M2-17-092 (A5187111), 00000M2-18-015 (FEG51905), 00000M2-18-006 (GON 4588912); c. Innova IGS 530, Model Number 5731195 - Lot Number (System ID): 00000M3-17-146 (479441CV4), 00000M3-18-007 (352726CATH1), 00000M3-17-136 (815759MCHCAR1), 00000M3-17-137 (856342INIGS), 00000M3-17-132 (856342IGS), 00000M3-17-148 (724658IGS530), 00000M3-18-004 (864573CL1), 00000M3-17-144 (901516INIGS), 00000M3-18-016 (GON 4480942), 00000M3-17-143 (304256INGS), 00000M3-18-005 (XV7945AR), 00000M3-18-005 (GON 1589001), 00000M3-18-011 (GON 1599555), 00000M3-17-150 (XVM317150), 00000M3-17-150 (4555829XV11), 00000M3-18-009 (GON 460387
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.