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U.S. Department of Health and Human Services

Class 2 Device Recall ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES

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 Class 2 Device Recall ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIESsee related information
Date Initiated by FirmNovember 24, 2021
Create DateMarch 04, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0725-2022
Recall Event ID 89375
510(K)NumberK141979 K161563 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductPhilips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
Code Information S/N: OUS 109
FEI Number 3016618143
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionPhilips Issued Medical Device Correction letter dated 11/24/21 to U.S.A, Customers via certified mailing from the United States Postal Service (USPS). Letters outside of the U.S.A. will be distributed through the Philips Markets Organizations. Letter states reason for recall, health risk and action to take: Philips will inspect the affected systems for leaks and repair as required. In addition, Philips will install an extended drip tray to prevent damage from any future leaks. This service will be provided free of charge for affected systems. A Philips service representative will contact customers with affected devices to arrange for the service. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377 (reference FCC 72200484).
Quantity in Commerce1 unit
DistributionUS 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.)
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
510(K)s with Product Code = OWB
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