FDA-Device2022-03-16Class II
Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
Philips North America Llc
Hazard
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.
Sold states
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.)
Affected count
1 unit
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0725-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief