Events

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
Australia
Event Source
DHTGA
Event Source URL
https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00297-1
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

Uninterruptible Power Supply (UPS) supplied with Philips Computed Tomography / Advanced Molecular...

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
Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd

Manufacturer Parent Company (2017)
Philips
Source
DHTGA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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