• AI
  • Molecular Imaging
  • CT
  • X-Ray
  • Ultrasound
  • MRI
  • Facility Management
  • Mammography

Philips gets FDA warning letter

Article

Philips Medical Systems North America of Shelton, CT, is responding to a warning letter from the Food and Drug Administration regarding its Integris 3000 family of vascular imaging and interventional x-ray systems. The letter claims that when the systems

Philips Medical Systems North America of Shelton, CT, is responding to a warning letter from the Food and Drug Administration regarding its Integris 3000 family of vascular imaging and interventional x-ray systems. The letter claims that when the systems are connected with a VCR, the high fluoroscopy mode may not fully comply with the fluoroscopic recording provisions of FDA regulations. Philips is investigating the letter's claims and plans to issue a corrective action. In the meantime, Integris 3000 users should make sure that the VCR is recording prior to using the high fluoroscopy mode, according to the company. Philips said that the letter does not affect its newer Integris 5000 products.

Recent Videos
Employing AI in Detecting Subdural Hematomas on Head CTs: An Interview with Jeremy Heit, MD, PhD
Pertinent Insights into the Imaging of Patients with Marfan Syndrome
What New Brain MRI Research Reveals About Cannabis Use and Working Memory Tasks
Current and Emerging Legislative Priorities for Radiology in 2025
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 2
A Closer Look at the New Appropriate Use Criteria for Brain PET: An Interview with Phillip Kuo, MD, Part 2
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 1
A Closer Look at the New Appropriate Use Criteria for Brain PET: An Interview with Phillip Kuo, MD, Part 1
Teleradiology and Breast Imaging: Keys to Facilitating Personalized Service, Efficiency and Equity
Current and Emerging Insights on AI in Breast Imaging: An Interview with Mark Traill, MD, Part 3
Related Content
© 2025 MJH Life Sciences

All rights reserved.