Software in Medical Devices, by MD101 Consulting

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Tag - Recall

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Friday, 15 April 2022

SaMD decommissioning, recall, removal and withdrawal

We saw in the previous post how the lifetime of a SaMD can be defined. Let's continue with the operations that can affect this lifetime.

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Friday, 10 August 2012

Miscellaneous of August

Hi everybody,

I was out of the office, I didn'it have time to write anything relevant about our favorite subjects.
Here is an interresting article of The Economist (link will be dead after a while) about open-source software.

Seen on the newsletters I receive for vigilance, the recall of a defibrillator due to software failure: here on MHRA website and here on ANSM Website (in french).

For those who spent their vacation on Mars and haven't heard about Proteus ingestible biomedical sensor yet, have a look at this article. This is a double performance: technical with an ingestible sensor, and regulatory with clearance through the new "de novo" FDA process.

And to end with a bit of futurology, this new article of EMDT about the future of medtech.


Thursday, 5 January 2012

Pfizer recalls Rheumatology Calculator smartphone App

Dozens of companies recall their medical devices every month. A recall happens when something wrong happened with the device, like a bad labeling or a bad sterilization. It's the responsibility of the manufacturer to warn ALL their customers and the government agencies that a given lot or batch of products has a defect. The batches shall be destroyed or sent back to the manufacturer for further analysis.
That's what happened to Pfizer with its Rheumatology Calculator, a smartphone app used to compute a score to assess the desease of patients according to complex algorithms. There is a bug in the app and it gives wrong results.

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