Z-0725-2022Class II

Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an...

Name: Z-0725-2022 Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an...
Creator: Philips North America Llc
Published: 2021-11-24
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-11-24 / Open, Classified / root cause: manufacturing process

FDA source

Philips North America Llc began a recall of Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031 on 2021-11-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0725-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-24
Posted: 2022-03-04
Recalling firm: Philips North America LLC
Product: Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Philips 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 commerce: 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.)
Product codes and lots: S/N: OUS 109

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0725-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0724-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-16	2022-03-04
Z-0725-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-16	2022-03-04

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)