FDA Medical Device Recalls (openFDA)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 5M20, Model Numbers: 722228 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
- Recall number
- Z-2287-2026
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product
- Philips Azurion 5M20, Model Numbers: 722228 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
- Status
- Open, Classified
- Initiated
- 2023-12-07
- Posted
- 2026-06-01
- Terminated
- not on file
- Reason
- 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
- 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
- 51 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI (01)00884838099234(21)67, (01)00884838099234(21)49, (01)00884838099234(21)10, (01)00884838099234(21)36, (01)00884838099234(21)64, (01)00884838099234(21)110, (01)00884838099234(21)328, (01)00884838099234(21)149, (01)00884838099234(21)213, (01)00884838099234(21)45, (01)00884838099234(21)159, (01)00884838099234(21)18, (01)00884838099234(21)231, (01)00884838099234(21)61, (01)00884838099234(21)204, (01)00884838099234(21)273, (01)00884838099234(21)76, (01)00884838099234(21)150, (01)00884838099234(21)132, (01)00884838099234(21)189, (01)00884838099234(21)17, (01)00884838099234(21)47, (01)00884838099234(21)38, (01)00884838099234(21)87, (01)00884838099234(21)128, (01)00884838099234(21)32, (01)00884838099234(21)23, (01)00884838099234(21)25, (01)00884838099234(21)62, (01)00884838099234(21)181, (01)00884838099234(21)177, (01)00884838099234(21)48, (01)00884838099234(21)153, (01)00884838099234(21)79, (01)00884838099234(21)80, (01)00884838099234(21)157, (01)00884838099234(21)24, (01)00884838099234(21)187, (01)00884838099234(21)26, (01)00884838099234(21)29, (01)00884838099234(21)122, (01)00884838099234(21)127, (01)00884838099234(21)6, (01)00884838099234(21)123, (01)00884838099234(21)124, (01)00884838099234(21)92, (01)00884838099234(21)215, (01)00884838099234(21)91, (01)00884838099234(21)205, (01)00884838099234(21)20, (01)00884838099234(21)37a.
- 510(k) numbers
- ["K172822","K181830","K200917"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3042175844
- Firm city
- Best
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28