PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1)…
Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure
Read the official notice →- Date
- 2023-06-07
- Country
- United States
- Brand
- Philips Medical Systems Nederland
- Product
- Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063,…
- Classification
- Class II
- Units
- Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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Loss of availability of the wireless foot switch during procedures.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2023-08-09
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FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2023-04-26
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FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution.Official notice → - 2022-05-11
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In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.US Nationwide and Worldwide DistributionOfficial notice → - 2022-02-23
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Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used…
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