Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x
Medical device recall Z-0213-2022. Published in FDA’s Enforcement Report on Nov 17, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement 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” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 17, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 428 (US); 581 (OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
428 (US); 581 (OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Software version 2.1.x Serial Number | Unique Device Identifier (UDI#) 140 (01)00884838099258(21)140 124 (01)00884838099241(21)124 75 (01)00884838099258(21)75 824 (01)00884838085251(21)824 182 (01)00884838099258(21)182 703416…
Every code shown here, 1,989 characters
Software version 2.1.x Serial Number | Unique Device Identifier (UDI#) 140 (01)00884838099258(21)140 124 (01)00884838099241(21)124 75 (01)00884838099258(21)75 824 (01)00884838085251(21)824 182 (01)00884838099258(21)182 703416 (01)00884838085268(21)703416 626 (01)00884838085251(21)626 697 (01)00884838085251(21)697 3 (01)00884838099203(21)3 703368 (01)00884838085268(21)703368 139 (01)00884838099258(21)139 159 (01)00884838099258(21)159 36 (01)00884838099241(21)36 266 (01)00884838099258(21)266 512 (01)00884838099258(21)512 703413 (01)00884838085268(21)703413 1410 (01)00884838085268(21)1410 703329 (01)00884838085268(21)703329 250 (01)00884838099258(21)250 226 (01)00884838099258(21)226 105 (01)00884838099272(21)105 360 (01)00884838099258(21)360 370 (01)00884838099258(21)370 1379 (01)00884838085268(21)1379 452 (01)00884838099258(21)452 141 (01)00884838085251(21)141 279 (01)00884838085251(21)279 644 (01)00884838085251(21)644 455 (01)00884838085268(21)455 48 (01)00884838099234(21)48 584 (01)00884838099258(21)584 239 (01)00884838099272(21)239 34 (01)00884838099258(21)34 131 (01)00884838099241(21)131 88 (01)00884838099258(21)88 890 (01)00884838085251(21)890 15 (01)00884838099210(21)15 19 (01)00884838099210(21)19 919 (01)00884838085268(21)919 33 (01)00884838099258(21)33 792 (01)00884838085268(21)792 469 (01)00884838085367(21)469 53 (01)00884838099258(21)53 469 (01)00884838085367(21)469 363 (01)00884838099258(21)363 409 (01)00884838099258(21)409 260 (01)00884838085282(21)260 261 (01)00884838085282(21)261 132 (01)00884838085275(21)132 17 (01)00884838099234(21)17 658 (01)00884838085268(21)658 425 (01)00884838099258(21)425 308 (01)00884838085367(21)308 189 (01)00884838099258(21)189 32 (01)00884838099234(21)32 131 (01)00884838085275(21)131 225 (01)00884838099258(21)225 235 (01)00884838099258(21)235 50 (01)00884838099258(21)50 209 (01)00884838085282(21)209 69 (01)00884838099241(21)69 23 (01)00884838099234(21)23 25 (01)00884838099234(21)25 107 (01)00884838099272(21)107 172…
FDA’s list runs to 29,862 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Domestic distribution nationwide. International distribution worldwide.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 24, 2021.
- FDA classified it on Nov 9, 2021.
- FDA’s Enforcement Report published it on Nov 17, 2021.
- FDA terminated it on Sep 26, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America Llc, of Cambridge, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- 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 29,862 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.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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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.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.