Z-2284-2026Class II

Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and...

Name: Z-2284-2026 Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and...
Creator: Philips Medical Systems Nederland B.v.
Published: 2023-12-07
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2023-12-07 / Open, Classified / root cause: software

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key on 2023-12-07. FDA classified it as Class II and gives the reason as "During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2284-2026
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-07
Posted: 2026-06-01
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Root cause tag: software
FDA root cause: Software design
Action: Philips issued an IMPORTANT PRODUCT NOTICE to its consignees on 12/7/2023 via USPS mail. The notice explained the problem with the device and the circumstances under which if could occur and actions to be taken to minimize the effect of the problem. The notice further instructed the user to: - Keep this Important Product Notice with the documentation of the system until Philips corrects your system. - Circulate this notice to all users of the system so that they are aware of the issue. - Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Important Product Notice. For further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.
Quantity in commerce: 16 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI (01)00884838099203(21)3, (01)00884838099203(21)7, (01)00884838085275(21)131, (01)00884838099203(21)54, (01)00884838085275(21)84, (01)00884838099203(21)6, (01)00884838099203(21)93, (01)00884838085275(21)132, (01)00884838099203(21)69, (01)00884838099203(21)9, (01)00884838099203(21)115, (01)00884838099203(21)85, (01)00884838099203(21)19, (01)00884838099203(21)49, (01)00884838099203(21)108, (01)00884838085275(21)108.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2284-2026
Recall number	Class	Status	Report date	Classified
Z-2284-2026	Class II	Ongoing	2026-06-10	2026-06-01
Z-2285-2026	Class II	Ongoing	2026-06-10	2026-06-01
Z-2286-2026	Class II	Ongoing	2026-06-10	2026-06-01
Z-2287-2026	Class II	Ongoing	2026-06-10	2026-06-01
Z-2288-2026	Class II	Ongoing	2026-06-10	2026-06-01
Z-2289-2026	Class II	Ongoing	2026-06-10	2026-06-01
Z-2290-2026	Class II	Ongoing	2026-06-10	2026-06-01
Z-2291-2026	Class II	Ongoing	2026-06-10	2026-06-01

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)