The Recall Desk
ModerateFDA (Devices)·Z-2387-2018·Announced 2018-07-18

GE Medical Systems Recalls Innova IGS Fluoroscopic X-ray Systems

GE Medical Systems is recalling 102 Innova IGS fluoroscopic X-ray systems due to a defect that may cause X-ray abort errors, resulting in the loss of imaging mode during use.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text describes a functional defect (loss of imaging mode) without reporting any injuries, illnesses, or deaths, and the hazard is not explicitly described as a high-risk pathogen or common allergen, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

GE Medical Systems, SCS is recalling 102 units of the Innova IGS 630, 520, 530, and 540 Interventional Fluoroscopic X-ray Systems. The recall covers devices distributed across 18 U.S. states and 25 international countries. The affected systems are identified by specific model numbers and System IDs (Lot Numbers) listed in the official recall documentation.

The recall was initiated because the Discovery IGS and Innova IGS systems may experience X-ray abort errors. This defect could result in the loss of imaging mode before or during fluoroscopic use. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

Healthcare facilities and users of these devices should contact GE Medical Systems for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
Manufacturer
GE Medical Systems, SCS
Category
Medical Device — Imaging Equipment
Hazard
Affected units
102

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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)

Distribution

Distributed in 16 states:

Part of a larger recall action

This product is one of 3 recalled by GE Medical Systems, SCS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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