INNOVA IGS 5 001Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

25 other recalls cover devices cleared under the same FDA submission (K122457, K181403); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Mar 18, 2024Open, Classified

   GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

   Z-1777-2024 · Root cause: Process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122457, K181403. One submission often covers many models, so check the product and lot details in each record.

• Z-1778-2024 · Mar 18, 2024 · Open, Classified
  GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
• Z-1782-2024 · Mar 18, 2024 · Open, Classified
  GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
• Z-1783-2024 · Mar 18, 2024 · Open, Classified
  GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
• Z-1864-2021 · Apr 19, 2021 · Terminated
  GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7
• Z-1201-2019 · Mar 15, 2019 · Open, Classified
  Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnos
• Z-1200-2019 · Mar 15, 2019 · Open, Classified
  Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagn
• Z-2386-2018 · Mar 29, 2018 · Terminated
  Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
• Z-2387-2018 · Mar 29, 2018 · Terminated
  Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
• Z-0763-2016 · Dec 18, 2015 · Terminated
  Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA
• Z-0414-2016 · Nov 13, 2015 · Terminated
  GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational
• Z-0413-2016 · Nov 13, 2015 · Terminated
  GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational i
• Z-1976-2015 · May 29, 2015 · Terminated
  GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surg
• Z-1985-2015 · May 29, 2015 · Terminated
  GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided sur
• Z-1974-2015 · May 29, 2015 · Terminated
  GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided
• Z-1977-2015 · May 29, 2015 · Terminated
  GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surg

…and 10 more.