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Latest From Philips Healthcare

Philips, Hamilton Medical To FDA: QMSR Shouldn’t Subject Devices To ISO Traceability Requirements

The makers of breathing machines said in comments to the US agency that it must address language in its draft Quality Management System Regulation that the companies say would place onerous traceability requirements on most medical devices.

Regulation Quality

Philips Breathing Machines Recall: 21,000+ Adverse Events Reported To FDA In 1 Year

The tens of thousands of Medical Device Reports sent to the US agency included 124 reports of death associated with Philips’ June 2021 recall of millions of BiPAPs, CPAPs, and other mechanical ventilator devices.

Recalls Safety

Escalation: FDA Wants Philips To Repair, Replace Or Give Refunds For Recalled Breathing Machines

The US FDA is weighing whether to force the embattled company to repair, replace or refund recalled BiPAP, CPAP and other mechanical ventilator devices. Philips Respironics may attend an “informal hearing” before the agency decides.

Enforcement FDA

Recalls And Multiple Market Challenges Test Philips’ Resilience Into Q1

Philips’ revenues contraction in the first quarter of 2022 was less than feared and its order book remains impressive, but challenges presented by the recall program and generic post-COVID factors for the year ahead remain substantial.

Commercial Sales & Earnings
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Company Information

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  • Digital Health
  • Medical Devices
    • Monitoring Equipment & Devices
    • Rehabilitation Equipment and Devices
    • Surgical Equipment & Devices
    • Diagnostic Imaging Equipment & Supplies
      • Digital Imaging
      • MRI, NMR
      • Ultrasound
      • X-ray
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