2023-05-26 13:57:39
health
This is the Philips Azurion mechanism, which would have a problem identified by the manufacturer itself.
26/5/2023
The Directorate of Medical Devices and Other Technologies of the National Institute of Food and Drug Surveillance (Invima) issued a safety report in which it informed the public about a difficulty that is occurring with an X-ray system that is used in national territory.
According to the health entity, it is the Allura Xper Philips cardiovascular X-ray system, which has the Invima registration 2019EBC-0002432-R1 and is imported by Philips Medical Systems Nederland, Philips India Limited and Philips Colombiana SAS
According to the Invima security report, the source of the pronouncement was the manufacturer itself. This organization informed the health entity that it found a “possible security problem”, something that in the long run causes the Philips Azurion system to lose its functionality. functionality of X-rays “in an unexpected way”.
These difficulties, warned Invima, could be related to a problem that is being generated in the software of the devices. Specifically, it is a mechanism that is used within the system and that is aimed at managing the number and size of the Registry Trace Files. In practice, this could cause the system to not be working properly.
For this reason, Invima issued its warning and gave some recommendations to patients and health authorities. “If you are using the referenced product, contact the importer, distributor or marketer to specify the actions to be taken”, Invima indicated in one of the warnings that were addressed to the general public.
Meanwhile, he asked the country’s Health Secretariats that if they identify that the aforementioned technology is being used in their jurisdictions, it is essential that they also contact the companies that import, distribute, or market the products to specify the measures that they must be taken.
In addition, they were asked to report adverse events related to this medical device directly to the Invima National Technovigilance Program.
Meanwhile, health service providers were asked to implement a product traceability process and follow the manufacturer’s instructions. “Owner establishments, importers, distributors and marketers must ensure that they implement and execute the action plan defined by the factory”, pointed out the Invima.
And he requested that “the institutional Tecnovigilance programs carry out an active search for the detection of events or adverse incidents that involve the medical device indicated in this alert and that they be notified to the Institute.”
Invima declared a product that preserves the lungs for transplantation as a Vital Medical Device Not Available
In the last hours, Invima also made another sanitary announcement due to a product that is required in Colombia and is not being easily obtained. After a review of the market, its officials declared a drug that preserves the lungs for transplantation as a Vital Medical Device Not Available.
“Understanding that the Solutions for the Preservation of Lungs for Transplantation Purposes are a fundamental input, since they are used to wash, store and transport lungs, the National Institute for Food and Drug Surveillance (Invima) carried out the corresponding analyzes to determine its availability in the country and analyze whether it should be included in the list of unavailable vitals”, Invima warned.
And he pointed out that, after the internal inquiries made by his officials, they found that in national territory there is only one holder of a sanitary registry for this product. Then, they determined that that importer has not brought the solution to the country in recent months.
Therefore, Invima considered that it is a “situation that could trigger a possible risk of shortage, taking into account that there is no substitute in the Colombian market for these solutions.”
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