International Medical Devices Database

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

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Type of Event
Safety alert
Date
2012-03-21
Event Country
Hong Kong
Event Source
DH
Event Source URL
https://www.mdco.gov.hk/english/safety/recalls/recalls_20120321c.html
Notes / Alerts

Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Extra notes in the data

Medical Device Safety Alert
Reason
Field safety notice: roche process systems manager software version 2.02.02c the health canada issued a type i medical device recall concerning the process systems manager (psm) software version 2.02.02c [model no.: 4944607001] manufactured by roche diagnostics ltd. according to health canada, this recall is about issue with the psm software version 2.02.02c and higher that leads to an unintended change of patient demographics in the psm database which could affect the interpretation of results within the psm environment. for details, please refer to the health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-mar_2012-eng.Php if you are in possession of the product, please contact your supplier for necessary actions.

Device

Process Systems Manager Software Version 2.02.02c

Model / Serial
Product Description
Medical Device Safety Alert: Roche Process Systems Manager Software Version 2.02.02c
Manufacturer
Roche Diagnostics Ltd

Manufacturer

Roche Diagnostics Ltd

Manufacturer Parent Company (2017)
Roche Holding AG
Source
DH

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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Safety Alert for Process Systems Manager Software Version 2.02.02c

What is this?

Device

Process Systems Manager Software Version 2.02.02c

Manufacturer

Roche Diagnostics Ltd