Recall of Uninterruptible Power Supply (UPS) supplied with Philips Computed Tomography / Advanced Molecular Imaging SystemsBrightView, BrightView X / XCTCardio MDForteGemini TF/ GXl (6 slice) / TF Astonish/ 16 Power/ GXL / TF 64 w/ TOF PerformanceIngenuity, Ingenuity Core/ Core 128/ CT/ CT 728326/ Flex/ TF PET/CTPrecedenceBrilliance CT 16 Slice/ 64 Channel/ Big Bore Oncology/ iCT/ iCT - BETA TEST SYSTEM/ iCT SPMX 16 Slice

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00297-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-01
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Without preventative maintenance, and/or periodic battery replacement, ups devices may fail, resulting in battery acid leakage, overheating, and/or the emission of fumes. all lead/acid battery-based ups devices are susceptible to this issue. hazards involved as a result of ups devices failing include, but are not limited to:· chemical burn· thermal burn· eye, nose and/or throat irritation.
  • Action
    Customers are advised to review the material supplied with the customer letter and implement a UPS maintenance program at their facility. If users detect an unusual odour, heat, or see liquid in the area of the UPS, do not touch the UPS or any surrounding liquid. Follow institution’s procedures for potentially hazardous material. Be aware of all people in the vicinity of the potentially hazardous situation, including but not limited to patients, staff, and service personnel. Contact the service provider immediately. This action has been closed-out on 09/08/2016.

Device

  • Model / Serial
    Uninterruptible Power Supply (UPS) supplied with Philips Computed Tomography / Advanced Molecular Imaging SystemsBrightView, BrightView X / XCTCardio MDForteGemini TF/ GXl (6 slice) / TF Astonish/ 16 Power/ GXL / TF 64 w/ TOF PerformanceIngenuity, Ingenuity Core/ Core 128/ CT/ CT 728326/ Flex/ TF PET/CTPrecedenceBrilliance CT 16 Slice/ 64 Channel/ Big Bore Oncology/ iCT/ iCT - BETA TEST SYSTEM/ iCT SPMX 16 SliceARTG Numbers: 98868, 117440, 117642, 118077, 158775
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    DHTGA