Events

Field Safety Notices about Healthcare (Suzhou) Co. Ltd for Multiva 1.5T systems T5, T10-NT, ACSNT, Intera 0.5T/1.0T, 1.5T, Achieva 1.5T, Multiva 1.5T, Ingenia CX 1.5T and Panorama 1.0T MR systems

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Philips Medical Systems Nederland B.V. BIU Magnetic Resonance-site Best / Philips.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here

Type of Event
Field Safety Notice
Event Number
V35335
Event Country
Ireland
Event Source
HPRA
Event Source URL
http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/summary-of-field-safety-notice-april-2018&id=bea90a26-9782-6eee-9b55-ff00008c97d0
Notes / Alerts

Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Extra notes in the data

Advice regarding a device modification. 3rd Party Publications

Device

Healthcare (Suzhou) Co. Ltd for Multiva 1.5T systems T5, T10-NT, ACSNT, Intera 0.5T/1.0T, 1.5T, ...

Model / Serial
Manufacturer
Philips Medical Systems Nederland B.V. BIU Magnetic Resonance-site Best / Philips

Manufacturer

Philips Medical Systems Nederland B.V. BIU Magnetic Resonance-site Best / Philips

Manufacturer Parent Company (2017)
Philips
Source
HPRA

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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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