FDA recall, , Moderate risk
Philips Azurion System
Issue 1 - System remains in continuous restart mode after the start-up.
Summary by Recall Canary from the FDA notice
What happened
Philips Medical Systems Nederland B.V., located in Best, Netherlands, recalled its Philips Azurion system with Software Version Number R3.1. The company identified two software issues that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data.
The first issue involves the system remaining in continuous restart mode after start-up, while the second issue, a longitudinal position error, applies only to systems with a Poly-G3 frontal stand.
The recall, which began on December 12, 2025, affects 228 units distributed internationally, including in countries such as AE, AR, AT, AZ, BE, BG, BH, BR, BS, CH, CL, CO, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, GB, GR, GT, ID, IE, IL, IN, IQ, IT, JE, JP, LB, MA, MO, NI, NL, NO, PE, PL, RO, SA, SE, SV, TR, UA, VE, VN, and ZA, as well as in U.S. states including Arkansas, Arizona, Colorado, Delaware, Idaho, Illinois, Indiana, Massachusetts, and Missouri.
The FDA added the recall to its Enforcement Report on January 16, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Philips Azurion system; Software Version Number: R3.1;
- UDI-DI
- 00884838099203
- 00884838099210
- 00884838099241
- 00884838099258
- 00884838099265
- 00884838099272
- 00884838099227
- 00884838099234
- 00884838116726
- 00884838116733
- 00884838116740
- 00884838116757
- 00884838116764
- 00884838116771
- 00884838116788
- 00884838116801
Recall details
- Company began the recall
- Sold in
International distribution in the countries of AE, Arkansas, AT, Arizona, BE, BG, BH, BR, BS, CH, CL, Colorado, CR, CY, CZ, Delaware, DK, DZ, EC, EG, ES, GB, GR, GT, Idaho, IE, Illinois, Indiana, IQ, IT, JE, JP, LB, Massachusetts, Missouri, NI, NL, NO, PE, PL, RO, SA, SE, SV, TR, UA, VE, VN, ZA;
- Company
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, Netherlands
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98108
- Recall number
- Z-1113-2026
- Quantity recalled
- 228 units (all OUS)
All recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
