Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally…

Class II, the middle of FDA’s three classes.

Codes to check against yours

US: (1) Model 722223 SN: 580 (01)00884838099241(21)580 (2) Model: 722224 SN: UDI: 1518 (01)00884838099258(21)1518 1317 (01)00884838099258(21)1317 1221 (01)00884838099258(21)1221 845 (01)00884838099258(21)845 974 (01)00884838099258(21)974…

FDA’s list runs to 4,227 characters. The first part is shown; the rest is on FDA’s record.

Worldwide distribution - US Nationwide distribution in the states of NY, PA, PR, TN, TX, VA, WA and the countries of Algeria, Armenia, Austria, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Macao, Macedonia, Malaysia, Morocco, Netherlands, Norway, Oman, Palestine, State of Panama, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom.

The states and territories these words name

• New York
• Pennsylvania
• Puerto Rico
• Tennessee
• Texas
• Virginia
• Washington

What FDA means by nationwide

The words say it went outside the United States too.

Ongoing, in FDA’s file.

• The firm began the recall on Feb 6, 2024.
• FDA classified it on Feb 22, 2024.
• FDA’s Enforcement Report published it on Feb 28, 2024.

• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., of Best, Netherlands.
• Who began it, in FDA’s words: Voluntary: Firm initiated.
• How the firm first told its customers: Letter.

• Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
• Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
• How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
• Whether anyone was hurt or fell ill: the report doesn’t say.
• How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
• FDA’s list of codes runs to 4,227 characters; the first part is shown here, and the rest is on FDA’s record.
• A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.

• U.S. Food and Drug Administration, Device recall enforcement reports.

  Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

• This record in openFDA