Reported Feb 18, 2026 · Ongoing
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number -…
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 4-6 · Best, N/A · N/A
Is this the product you have?
- Azurion 3 M15 System Model Numbers
(1) 722064(2) 722222(3) 722230(4)722280(OUS only)
- Software Version Number - All versions
R1.XR2.XR3.X
- Lot codes and dates
- 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 NumbersAll
- System Model Numbers
- Amount recalled
- 802 units (45 US, 757 OUS)
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips Medical Systems Nederland B.v. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.