Health Products

Allura Xper and Allura CV20 Systems

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Allura Xper and Allura CV20 Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Model or catalogue numberLot or serial numberAffected products
722028307Allura Xper FD20 (Product Of Alluraclarity Family)
7220281655Allura Xper FD20 (Product Of Alluraclarity Family)
722027306Allura Xper FD10/10 (Product Of Alluraclarity Family)

Issue

Philips has identified a potential safety issue in certain Philips Allura Xper and Allura CV20 Systems that have a Laird cooling unit installed which may result in a loss of imaging functionality and/or thermal events. Certain Philips Allura Xper and Allura CV20 systems use a Laird cooling unit to control the flat detector's temperature. This cooling unit is housed in a system cabinet in the technical room. Philips has identified that a limited number of Allura Xper and Allura CV20 systems may lack a drip tray beneath the cooling unit. This component is intended to prevent potential leaking coolant liquid from contacting electrical components. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. Electrical short-circuits could cause elevated temperatures in insulating materials, which may result in smoke formation. In severe cases, deterioration of insulation could produce sparks, and combined with flammable coolant liquid and high temperatures, lead to fire.

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