Philips Azurion 7 M12 System Recall: Table May Move Unexpectedly When Reset Button Pressed
Philips recalls Azurion 7 M12 systems with specific model numbers and software versions due to risk of unexpected table movement when pressing Reset Geometry button, even with lock engaged.
Use caution until it’s fixed
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Contact the company
What happened, in plain English
Philips is recalling Azurion 7 M12 medical imaging systems with model numbers 722078, 722223, and 722233. The issue involves the table moving unexpectedly when the Reset Geometry button is pressed, even when a table lock is active. This could lead to potential injury during medical procedures. Read more at govinfonow.com/recall/50091-philips-azurion-7-m12-system-recall-table-may-move-unexpectedly.
Source Summary by GovInfoNow · govinfonow.com/recall/50091-philips-azurion-7-m12-system-recall-table-may-move-unexpectedly · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1348-2026
Cite this page
“Philips Azurion 7 M12 System Recall: Table May Move Unexpectedly When Reset Button Pressed.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50091-philips-azurion-7-m12-system-recall-table-may-move-unexpectedly. Based on FDA recall #Z-1348-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1348-2026%22&limit=1).
Why it’s dangerous
Pressing the Reset Geometry button can cause the table to move unexpectedly, even when the table lock is engaged. This movement could potentially cause injury to patients or staff during medical procedures if the table shifts unexpectedly.
Who’s affected
Medical facilities using Philips Azurion 7 M12 systems with the listed model numbers and software versions are most at risk. Patients and staff during imaging procedures could be affected if the table moves unexpectedly.
How to tell if you have this one
Check for model numbers 722078, 722223, or 722233 on the system. The software version is R1.X, R2.X, or R3.X. The system was sold with specific serial numbers and UDI-DIs listed in the recall notice.
- Brand
Philips- Category
Medical device
All 8 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, FrenchPolynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1344-2026 | Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X; System Model Numbers: (1) 722063, (2) 722221, (3) 722229; UDI-DIs: (1) 884838085275, (2) 884838099203, (3) 884838116726; Serial Numbers: All; | 291 units (27 US, 264 OUS) |
| Z-1345-2026 | Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X; System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); UDI-DIs: (1) 884838085282, (2) 884838099210, (3) 884838116733, (4)N/A; Serial Numbers: All; | 802 units (45 US, 757 OUS) |
| Z-1346-2026 | Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X; System Model Numbers:(1)722067, (2)722225, (3)722235; UDI-DIs:(1)884838085350, (2)884838099265, (3)884838116788; Serial Numbers: All; | 655 units (106 US, 549 OUS) |
| Z-1347-2026 | Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X; System Model Numbers: (1)722068, (2)722226, (3)722236; UDI-DIs: (1)884838085367, (2)884838099272, (3)884838116801; Serial Numbers: All; | 1503 units (326 US, 1177 OUS) |
| Z-1348-2026 | Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X; System Model Numbers: (1)722078, (2)722223, (3)722233; UDI-DIs: (1)884838085251, (2)884838099241, (3)884838116764; Serial Numbers: All; | 1979 units (365 US, 1614 OUS) |
| Z-1349-2026 | Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X; System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); UDI-DIs: (1)884838085268, (2)884838099258, (3)884838116771, (4)N/A; Serial Numbers: All; | 5136 units (1743 US, 3393 OUS) |
| Z-1350-2026 | Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X; System Model Numbers: (1)722227, (2)722231; UDI-DIs: (1)884838099227, (2)884838099258, (3)884838116740; Serial Numbers: All; | 326 units (10 US, 316 OUS) |
| Z-1351-2026 | Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X; System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); UDI-DIs: (1)884838099234, (2)884838116757, (3)N/A; Serial Numbers: All; | 922 units (101 US, 821 OUS) |
What to do — step by step
Check System Model
Identify the model number on your Azurion 7 M12 system to confirm if it is one of 722078, 722223, or 722233.
Review Software Version
Ensure your software version is R1.X, R2.X, or R3.X to determine if it is affected by this recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Botswana, Brazil, Brunei Darussal,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 23 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1348-2026 (January 26, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1348-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.