Device recall: Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product…
Class II FDA enforcement event 75157. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. 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 24 Aug 2016. The firm address in the FDA record is in Cleveland, OH. FDA put the recall in Class II. FDA event 75157 has 4 product records. The first FDA enforcement report date is 12 Oct 2016. The record gives the status Terminated, with the termination date 2 Jul 2018.
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 in the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, GA, IA, IL, IN, FL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NH, NM, NV, NY, OH, OK, OR, PA,…
Recalling firm
Philips Medical Systems, Cleveland, OH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0009-2017 | Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. | 185 | Class II | Terminated | 12 Oct 2016 |
| Z-0010-2017 | Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. | 358 | Class II | Terminated | 12 Oct 2016 |
| Z-0011-2017 | Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. | 524 | Class II | Terminated | 12 Oct 2016 |
| Z-0012-2017 | Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. | 235 | Class II | Terminated | 12 Oct 2016 |
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 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 4Median 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 |
| 25 Sep 2025 | Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X; | Device | Class II | 3 |
| 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 |
| 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-0009-2017The 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 75157. https://recallregister.com/fda/ii/75157/. 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 in the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, GA, IA, IL, IN, FL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NH, NM, NV, NY, OH, OK, OR, PA,…
- What quantity of product is in FDA event 75157?
- The event has 4 product records. The first record gives this quantity:
185
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.