Device recall: Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Class II FDA enforcement event 89020. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or landscape orientation with an angle of 0 or +/-90 degrees relative to the 3D scan…
Class II, in the words of FDA
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
Philips Healthcare started this device recall on 24 Sep 2021. The firm address in the FDA record is in Andover, MA. FDA put the recall in Class II. FDA event 89020 has 1 product record. The first FDA enforcement report date is 1 Dec 2021. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution
Recalling firm
Philips Healthcare, Andover, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: FDA Mandated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0238-2022 | Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) | 226 units | Class II | Ongoing | 1 Dec 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 10
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Aug 2023 | Incisive CT, software version 5.0 | Device | Class II | 1 |
| 2 Feb 2022 | Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x | Device | Class II | 1 |
| 22 Sep 2021 | DigitalDiagnost C90 | Device | Class II | 3 |
| 26 May 2021 | Azurion systems with software release R2.0.x | Device | Class II | 1 |
| 21 Dec 2018 | DigitalDiagnost C50, Stationary X-ray System | Device | Class II | 1 |
| 11 Jun 2018 | Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interven | Device | Class II | 3 |
| 10 Nov 2015 | Philips Healthcare DigitalDiagnost stationary X-ray system | Device | Class II | 2 |
| 6 Sep 2015 | Philips Healthcare Brilliance 64 Computed Tomography X-Ray System | Device | Class II | 7 |
| 13 Jan 2014 | InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0238-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 89020. https://recallregister.com/fda/ii/89020/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution
- What quantity of product is in FDA event 89020?
- The FDA record gives this quantity:
226 units
- How did the recall start?
- The FDA record says:
FDA Mandated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.