🔍 RecallPedia

Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems

Class I - Dangerous
🏥 Medical Devices Recalled: March 29, 2018 GE Medical Systems, SCS Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GE Medical Systems, SCS
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems

Product Codes/Lot Numbers:

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)

Distribution:

Distributed in: US, AR, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, WI, WV

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2387-2018

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