Device recall: Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive…
Class II FDA enforcement event 93966. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
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 MEDICAL SYSTEMS NEDERLAND B.V. started this device recall on 6 Feb 2024. The firm address in the FDA record is in Best. FDA put the recall in Class II. FDA event 93966 has 3 product records. The first FDA enforcement report date is 28 Feb 2024. 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.
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,…
Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, N/A, Netherlands.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1176-2024 | Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280 | 14 units | Class II | Ongoing | 28 Feb 2024 |
| Z-1177-2024 | Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228 | 27 units | Class II | Ongoing | 28 Feb 2024 |
| Z-1178-2024 | Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226 | 10 units US; 124 units OUS | Class II | Ongoing | 28 Feb 2024 |
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 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 3Median of the firm: 1
- Events of the firm on the register
- 59
Other events of the firm
Official channels
- FDA enforcement report Z-1176-2024The 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.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 93966. https://recallregister.com/fda/ii/93966/. 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:
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,…
- What quantity of product is in FDA event 93966?
- The event has 3 product records. The first record gives this quantity:
14 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.