
Patient Table Correction: Philips Updates Use Instructions for Allura and Azurion Systems due to Patient Fall Risk from Incorrectly Positioned Mattresses
Philps is updating use instructions for Allura and Azurion interventional fluoroscopy systems with patient tables after identifying some situations that may result in the patient falling from the table. These situations include: the mattress slipping from the table during patient transfer, incorrect positioning of the neuro mattress on the table, or if the incorrect mattress is being used on the table.
The FDA has identified this as a Class I recall, the most serious type of recall. This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Questions?
Customers in the U.S. with questions about this recall should contact their local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions).
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