Health product recall

Allura Xper and Allura CV20 Systems

Last updated

Summary

Product
Allura Xper and Allura CV20 Systems
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Allura Xper FD10/10 (Product Of Alluraclarity Family) 306 722027
Allura Xper FD20 (Product Of Alluraclarity Family) 1655 722028
Allura Xper FD20 (Product Of Alluraclarity Family) 307 722028

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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Philips Medical Systems Nederland B.V.

Veenpluis 6, Best, Netherlands, 5684 PC

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81455

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