Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.
USPhilips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.
Recalling Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Reason for Recall / Hazard
TranslatedNine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.
Product Description & Identification
TranslatedPhilips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.
Affected Products
TranslatedPhilips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.
Additional Source Details
| Field | Value |
|---|---|
| City | Best |
| Event id | 98071 |
| Address 1 | Veenpluis 4-6 |
| Code info | Software Version: R3.0. 1. Model Number: 722229. UDI Numbers: (01)00884838116726(21)22, (01)00884838116726(21)15, (01)00884838116726(21)16, (01)00884838116726(21)6, (01)00884838116726(21)8, (01)00884838116726(21)4, (01)00884838116726(21)24, (01)00884838116726(21)26, (01)00884838116726(21)20, (01)00884838116726(21)25, (01)00884838116726(21)11, (01)00884838116726(21)21, (01)00884838116726(21)13, (01)00884838116726(21)7, (01)00884838116726(21)10, (01)00884838116726(21)2, (01)00884838116726(21)3, (01)00884838116726(21)29. 2. Model Number: 722230. UDI Numbers: (01)00884838116733(21)2, (01)00884838116733(21)40, (01)00884838116733(21)9, (01)00884838116733(21)1, (01)00884838116733(21)38, (01)00884838116733(21)10, (01)00884838116733(21)45, (01)00884838116733(21)7, (01)00884838116733(21)27, (01)00884838116733(21)28, (01)00884838116733(21)39, (01)00884838116733(21)4, (01)00884838116733(21)5, (01)00884838116733(21)23, (01)00884838116733(21)41, (01)00884838116733(21)20, (01)00884838116733(21)19... [TRUNCATED] |
| Postal code | N/A |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 990 units |
| Reason for recall | Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251208 |
| Initial firm notification | |
| Center classification date | 20260114 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. M...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
Check Other Products In Your Household
Free Safety ToolsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Overview
- Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Chile, Colombia, Cote de'Ivore, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Kosovo, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Palestine, Philippines, Poland, Portugal, R¿union, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkiye, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.
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🚨 SAFETY ALERT: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. - Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234. Check if your household is affected: https://therecallfile.com/recalls/philips-azurion-systems-r3-0-includes-the-following-label-descriptions/FDA-Z-1079-2026
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