Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
This recall has been terminated (originally issued October 5, 2018).
- Company
- Ge Medical Systems, Scs
- Recall Initiated
- March 29, 2018
- Posted
- October 5, 2018
- Terminated
- June 15, 2021
- Recall Number
- Z-2387-2018
- Quantity
- 102 devices total
- Official Source
- View on FDA website ↗
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.
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 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)
Root Cause
Process control
Action Taken
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.