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Published: 2026-02-18Captured: 2026-02-24PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Product: 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
FDA issued a Class II enforcement action. Affects PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table .
- •Classification: Class II
- •Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- •Status: Ongoing
- •Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, A...
Reason
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
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...
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