Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller withou...
FDA Recall #Z-0725-2022 — Class II — November 24, 2021
Product Description
Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
Reason for Recall
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
Recalling Firm
Philips North America Llc — Cambridge, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1 unit
Distribution
US Nationwide Foreign: Argentina Austria Bangladesh Brazil Chile China Denmark Dominican Republic France Germany Greece India Indonesia Iran Israel Italy Japan Korea, Republic of Malaysia Mexico Netherlands Philippines Russian Federation Saudi Arabia South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey United Kingdom Virgin Islands (U.S.)
Code Information
S/N: OUS 109
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.