Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 21, 2026
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers: 722228, 722281. 5. Azurion 7 B12. Model Numbers: 722067, 722225. 6. Azurion 7 B20. Model Numbers: 722068, 722226. 7. Azurion 7 M12. Model Numbers: 722078, 7222
Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Medical Systems Nederland B.v. recalled Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the followin… - a moderate-severity action.
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the followin… was recalled by Philips Medical Systems Nederland B.v. in January 21, 2026. Reason: Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple dri…. Check the official notice for the remedy. Verify recall #Z-1091-2026 with the FDA Devices before acting.
The recall
Philips Medical Systems Nederland B.v. issued this moderate-severity FDA Devices recall-Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple dri….
- Moderate
- severity level
- 10K units
- affected scope
- Class II
- classification
- January 21, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1091-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1091-2026) was formally reported on January 21, 2026, with the manufacturer initiating the action on December 12, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Philips Medical Systems Nederland B.v. is listed as the recalling firm, operating out of Best. Federal records list the affected scope as 10,466 units.
The documented reason for this recall is: Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the sta… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Bots…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10,466 units
Related Recalls
6
3 from same agency
Product description
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers: 722228, 722281. 5. Azurion 7 B12. Model Numbers: 722067, 722225. 6. Azurion 7 B20. Model Numbers: 722068, 722226. 7. Azurion 7 M12. Model Numbers: 722078, 722223. 8. Azurion 7 M20. Model Numbers: 722079, 722224, 722282.
Reason for recall
Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1091-2026 |
| Date reported | January 21, 2026 |
| Date initiated | December 12, 2025 |
| Recalling firm | Philips Medical Systems Nederland B.v. |
| Firm location | Best |
| Affected scope | 10,466 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1091-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers: 722228, 722281. 5. Azurion 7 B12. Model Numbers: 722067, 722225. 6. Azurion 7 B20. Model Numbers: 722068, 722226. 7. Azurion 7 M12. Model Numbers: 722078, 722223. 8. Azurion 7 M20. Model Numbers: 722079, 722224, 722282.. Recalled by Philips Medical Systems Nederland B.v.. Units affected: 10,466 units.
Why was this product recalled? ▼
Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 21, 2026. Severity: Moderate. Recall number: Z-1091-2026.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, 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, State of, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine/United Arab Emirate, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Vietnam, Yemen..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1091-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 21, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.