Class 2 Device Recall Innova IGS 630/520/530/540 Interventional Fluoroscopic Xray Systems

• Date Initiated by Firm: March 29, 2018
• Date Posted: October 05, 2018
• Recall Status: Terminated on June 15, 2021
• Recall Number: Z-2387-2018
• Recall Event ID: 80177
• 510(K)Number: K111209 K122457
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
• Code Information: 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 4603874), 00000M3-18-006 (XV709531BU8), 00000M3-18-003 (GON 4587457), 00000M3-18-003 (XVM3-18-003), 00000M3-18-023 (082416110059), 00000M3-17-135 (082416160068), 00000M3-18-018 (082416120077), 00000M3-17-142 (082416120092), 00000M3-17-152 (082416030051), 00000M3-18-024 (GON 4619686), 00000M3-18-022 (GON 4615780), 00000M3-17-140 (082416160075), 00000M3-17-139 (082416100140), 00000M3-18-021 (GON 4611356), 00000M3-17-141 (082416090100), 00000M3-17-145 (082416100152), 00000M3-18-020 (082416140030), 00000M3-18-017 (082416230041), 00000M3-17-134 (082416250025), 00000M3-17-151 (082416250024), 00000M3-17-133 (082416270031), 00000M3-18-008 (GON 4537575), 00000M3-17-147 (083016246178617), 00000M3-17-154 (5973XR0127), 00000M3-17-153 (5512XR0234), 00000M3-18-013 (GON 4601349), 00000M3-18-015 (GON 4604677), 00000M3-18-002 (6073XR0067), 00000M3-18-012 (GON 4496858), 00000M3-18-001 (RU1079VA01), 00000M3-17-149 (16055VAS01), 00000M3-17-138 (5973XR0121), 00000M3-17-155 (5973XR0112); d. Innova IGS 540 Model Number 5731196- Lot Number (System ID): 00000M4-17-053 (0770385IGS540), 00000M4-18-001 (716631INNOVAIGS), 00000M4-17-052 (215481IGS1), 00000M4-18-002 (215949IGS1), 00000M4-18-004 (843792IGS540), 00000M4-17-048 (253874IR), 00000M4-18-003 (GON 4537782), 00000M4-17-049 (082416040090), 00000M4-18-005 (GON 4619684), 00000M4-17-047 (082416240024), 00000M4-17-050 (082416100144), 00000M4-17-051 (PL1107VA05)
• Recalling Firm/ Manufacturer: GE Medical Systems, SCS; 283 rue de la Miniere; Buc France
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: GE Healthcare notified customers on approximately 03/29/2018, via an URGENT MEDICAL DEVICE CORRECTION letter. Safety instructions included that before each use, to ensure the IGS system is fully functional as indicated in the GE product labeling and follow each facility's established procedures before and during each use to manage the patient if a repeated X-ray abort error occurs during the procedure or in the case a complete loss of fluoroscopic viewing capability may occur. If the problem persists, customers are instructed to contact their local GE Healthcare Service Representative. Additionally, customers are instructed that GE Healthcare will correct all affected products at no cost and a GE Healthcare representative will contact each customer to arrange for the correction. Questions or concerns regarding the notification can be directed to GE Healthcare Service at 1-800-437-1171 or the local Service Representative.
• Quantity in Commerce: 102 devices total
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OWB and Original Applicant = GE HEALTHCARE