International Medical Devices Database

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.

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Type of Event
Recall / Field Safety Notice
Event ID
mdprc 073 10 15 000
Event Initiated Date
2015-10-21
Event Country
Saudi Arabia
Event Source
SFDA
Event Source URL
https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8389
Notes / Alerts

Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Extra notes in the data

Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Mrx model m3535a with software version f.03.06 and earlier, and model m3536a with version t.00.05 and earlier may stop the automated ready-for-use (rfu) test in an abnormal state when the device is turned off.

Device

HeartStart MRx Defibrillator/Monitor with software versions F.03.06 and T.00.05

Model / Serial
Units Affected: MRx unit types with software versions F.03.06 (M3535A) and T.00.05 (M3536A) and earlier and the following part numbers: PMS Number: 861288 Part Number: M3535A PMS Number: 989803132391 Part Number: M3535ATZ PMS Number: 861289 Part Number: M3536A PMS Number: 989803132401 Part Number: M3536ATZ PMS Number: 861314 Part Number: M3536J PMS Number: 861464 Part Number: M3536M PMS Number: 861481 Part Number: M3536M2 PMS Number: 861483 Part Number: M3536M4 PMS Number: 861484 Part Number: M3536M5 PMS Number: 861491 Part Number: M3536M6 PMS Number: 861465 Part Number: M3536MC
Product Description
Defibrillator/Monitor
Manufacturer
Philips Healthcare

Manufacturer

Philips Healthcare

Manufacturer Parent Company (2017)
Philips
Manufacturers representative
Al-Faisaliah Medical System, Riyadh, (01) 2119948
Source
SFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

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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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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What is this?

Device

HeartStart MRx Defibrillator/Monitor with software versions F.03.06 and T.00.05

Manufacturer

Philips Healthcare