• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » FDA dings Philips on InnerCool RTx component recall

FDA dings Philips on InnerCool RTx component recall

January 15, 2014 By Chris Walker

FDA dings Philips on InnerCool RTx component recall

The FDA dinged Philips (NYSE:PHG) for tardiness in its notification of the recall of a component for its InnerCool RTx body temperature control device in a warning letter sent last month.

Philips issued a recall in January 2012 of the main control board for the InnerCool device, which is used to raise or lower the body’s core temperature, according to the warning letter.

But Philips "failed or refused to furnish material or information respecting the device" within the 10-day window mandated by the federal watchdog agency, according to the letter. The recall was prompted by the potential for the control board to generate low patient temperature readings, according to the agency.

And Philips’ August 20, 2013, response "did not address the above referenced corrections and removals, and did not provide any information to our office regarding the above events," according to the FDA.

Philips has 15 business days from the date it received the letter to let the FDA know the details of the recall and what steps it took to address the problem and what it will do to prevent it from happening again, according to the letter.

Filed Under: Food & Drug Administration (FDA), News Well, Recalls, Regulatory/Compliance Tagged With: Philips, Warning Letter

More recent news

  • Ambu wins FDA clearance for first single-use cysto-nephroscope
  • Tandem Diabetes Care pairs t:slim X2 pump with Abbott FreeStyle Libre 3 Plus in U.S.
  • Ypsomed, CamDiab to integrate Abbott dual glucose-ketone sensor into automated insulin delivery system
  • Johnson & Johnson MedTech launches new Volt plating systems for radius, humerus
  • PharmaSens, SiBionics collab on all-in-one insulin patch pump

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy