Recall of Thousands of MRI Scanners Issued by US FDA
By HospiMedica International staff writers Posted on 23 Feb 2015 |
The United States (US) Food and Drug Administration (FDA) has issued a Class 1 Recall notice for a large number of GE Healthcare (Chalfont St. Giles, Buckinghamshire, UK) Magnetic Resonance Imaging (MRI) systems. All MRI systems using superconducting magnets, manufactured from 1985 to the present are affected. The notice was dated February 18th, 2015.
Already on January 6, 2015, GE Healthcare had sent an "Urgent Medical Device Correction" letter to hospital administrators/risk managers, radiology department managers, and radiologists, in the US and around the world. The letter described the safety issue, safety instructions, affected product details, product correction and contact information. The letter was necessary when GE Healthcare discovered that the Magnet Rundown Units (MRU) on its imaging devices may not be properly connected.
To correct the issue, GE Healthcare has instructed customers to perform preventative measures to confirm that the MRU is connected to the magnet. The measures consist of a four-step test on the MRU. The steps are explained on the GE Healthcare and FDA websites.
According the FDA recall notice, “In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries.”
Related Links:
GE Healthcare
US Food and Drug Administration (FDA)
Already on January 6, 2015, GE Healthcare had sent an "Urgent Medical Device Correction" letter to hospital administrators/risk managers, radiology department managers, and radiologists, in the US and around the world. The letter described the safety issue, safety instructions, affected product details, product correction and contact information. The letter was necessary when GE Healthcare discovered that the Magnet Rundown Units (MRU) on its imaging devices may not be properly connected.
To correct the issue, GE Healthcare has instructed customers to perform preventative measures to confirm that the MRU is connected to the magnet. The measures consist of a four-step test on the MRU. The steps are explained on the GE Healthcare and FDA websites.
According the FDA recall notice, “In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries.”
Related Links:
GE Healthcare
US Food and Drug Administration (FDA)
Latest Business News
- Johnson & Johnson Acquires Cardiovascular Medical Device Company Shockwave Medical
- Mindray to Acquire Chinese Medical Device Company APT Medical
- Olympus Acquires Korean GI Stent Maker Taewoong Medical
- Karl Storz Acquires British AI Specialist Innersight Labs
- Stryker to Acquire French Joint Replacement Company SERF SAS
- Medical Illumination Acquires Surgical Lighting Specialist Isolux
- 5G Remote-Controlled Robots to Enable Even Cross-Border Surgeries
- International Hospital Federation Announces 2023 IHF Award Winners
- Unprecedented AI Integration Transforming Surgery Landscape, Say Experts
- New WHO Guidelines to Revolutionize AI in Healthcare
- Getinge Acquires US-Based Medical Equipment Provider Healthmark Industries
- Global Surgical Lights Market Driven by Increasing Number of Procedures
- Global Capsule Endoscopy Market Driven by Demand for Accurate Diagnosis of Gastrointestinal Conditions
- Global OR Integration Market Driven by Need for Improved Workflow Efficiency and Productivity
- Global Endoscopy Devices Market Driven by Increasing Adoption of Endoscopes in Surgical Procedures
- Global Minimally Invasive Medical Devices Market Driven by Benefits of MIS Procedures