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Fri, Jul 04, 2025

Infusion pump

Home » Topics » Medical devices » Infusion pump
  • Cloud cybersecurity
    March 10, 2022
    By Mark McCarty

    FDA says PTC Axeda software vulnerabilities affect wide range of medical devices

    The U.S. FDA has issued an advisory regarding vulnerabilities identified in the Axeda line of remote access software published by PTC Inc., which may affect more than 100 products made by dozens of manufacturers. The vulnerability could allow a hacker to trigger changes in the operation of the affected devices, a massive risk to patients undergoing medical imaging and radiotherapy procedures. The FDA notice stated that the Axeda Agent and desktop server programs are the subject of a notice by the Cybersecurity & Infrastructure Security Agency (CISA), which characterizes the vulnerability as requiring only a low-complexity attack to exploit.
  • Regulatory recall
    Aug. 13, 2021
    By Mark McCarty

    Baxter’s Dose IQ software the subject of a class I recall

    The FDA applied a class I tag to the recall of Dose IQ software used in infusion pumps made by Baxter Healthcare because of a defect in the software, although there have been no reported injuries or fatalities. The defect is blamed for creating mismatches between the drug library and the drug loaded into the infusion pump, which can lead to potentially deadly over- or under-infusion of the medication.
  • April 19, 2021

    Regulatory front for April 19, 2021

    The latest global regulatory news, changes and updates affecting medical devices and technologies, including: BD Alaris pumps recalled over keypad problems.
Read More

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