Z-0471-2022Class II

Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up...

Name: Z-0471-2022 Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up...
Creator: Philips North America Llc
Published: 2021-11-12
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-11-12 / Terminated / root cause: software

FDA source

Philips North America Llc began a recall of Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue... on 2021-11-12. FDA classified it as Class II and gives the reason as "(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0471-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-12
Posted: 2022-01-10
Terminated: 2024-02-05
Recalling firm: Philips North America LLC
Product: Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: (1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available
Root cause tag: software
FDA root cause: Software design
Action: Philips issued Field Safety Notice on 11/12/21 U.S.A, Customer notified via certified mailing from the United States Postal Service (USPS). Letters outside of the U.S.A. will be distributed through the Philips Markets Organization. Letter states reason for recall, health risk and action to take: Start-up problem: If the start-up problem occurs, perform a Cold Restart* of the system. b) Emergency stop recovery problem: If the emergency stop recovery problem occurs, perform a new Warm Restart* of the system. c) Place this Field Safety Notice with the documentation of the system until Philips has installed a software update in your system. d) Circulate this notice to all users of this device so they are aware of the product issues. e) Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Field Safety Notice. * The system restart options are described in section 4.2 of the Instructions for Use. 5. Describe the actions planned by Philips IGT Systems to correct these problems: These problems will be resolved by a software update (available in November 2021). You will be contacted by your local Philips representative to schedule the update of your system. If you need any further information, please contact your local Philips representative (reference to FC072200502).
Quantity in commerce: 10 units (1 US and 9 OUS)
Distribution: Worldwide distribution - US Nationwide distribution in the state of WA and the countries of France, Germany, Japan, Poland, United Kingdom.
Product codes and lots: US: Model 722068 Azurion 7 B20 S/N: 109 UDI: (01)00884838085367(21)109. OUS: Model: S/N UDI: 722226 Azurion 7 B20 176 (01)00884838099272(21)176; 722228 Azurion 5 M20 3 (01)00884838099234(21)3; 722221 Azurion 3 M12 8 (01)00884838099203(21)8; 722225 Azurion 7 B12 16 (01)00884838099265(21)16; 722225 Azurion 7 B12 73 (01)00884838099265(21)73; 722226 Azurion 7 B20 42 (01)00884838099272(21)42; 722226 Azurion 7 B20 157 (01)00884838099272(21)157; 722224 Azurion 7 M20 293 (01)00884838099258(21)293; 722078 Azurion 7 M12 220 (01)00884838085251(21)220

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0471-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0471-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-10

Product code OWB

K181830Class IIAzurion R2.0Philips Medical Systems Nederland B.V. / cleared 2018-08-02

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)