Reported Jul 18, 2018 · Terminated
Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
GE Medical Systems, SCS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, SCS · 283 rue de la Miniere · Buc · N/A
Is this the product you have?
- Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 5730860082416160071Innova IGS 630, - 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) 5731194082416040075Innova IGS 520, - 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) 5731195082416110059082416160068082416120077082416120092082416030051082416160075082416100140082416090100082416100152082416140030082416230041082416250025082416250024082416270031Innova IGS 530, - 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) 5731196-082416040090082416240024082416100144Innova IGS 540 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) - Amount recalled
- 102 devices total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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