Device recall: Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
Class II FDA enforcement event 97699. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the…
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 started this device recall on 25 Sep 2025. The firm address in the FDA record is in Cambridge, MA. FDA put the recall in Class II. FDA event 97699 has 3 product records. The first FDA enforcement report date is 5 Nov 2025. 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.
Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA; International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland, France, Germany,…
Recalling firm
PHILIPS MEDICAL SYSTEMS, Cambridge, MA.
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-0375-2026 | Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X; | 105 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0376-2026 | Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X; | 165 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0377-2026 | Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X; | 1 unit (OUS only) | Class II | Ongoing | 5 Nov 2025 |
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 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 3Median of the firm: 2
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Jun 2026 | Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades | Device | Class II | 3 |
| 7 Mar 2026 | Philips Spectral CT on Rails. Model Number: 728334. | Device | Class II | 1 |
| 13 Dec 2023 | Spectral CT on Rails: Software Version 5.1.0.X, model 728334. | Device | Class II | 2 |
| 11 Feb 2022 | CombiDiagnost R90 1.0 (709030) | Device | Class II | 2 |
| 24 Aug 2016 | Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectiona | Device | Class II | 4 |
| 8 Jan 2016 | DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #45980020 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0375-2026The 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 97699. https://recallregister.com/fda/ii/97699/. 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:
Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA; International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland, France, Germany,…
- What quantity of product is in FDA event 97699?
- The event has 3 product records. The first record gives this quantity:
105 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.