CLASS II ONGOING Device recall · Reported 22 Nov 2023 · FDA Enforcement Report
Brilliance CT Big Bore Oncology recalled by Philips North America
Philips North America is recalling Brilliance CT Big Bore Oncology, distributed nationwide in the US. The recall was initiated on 9 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0294-2024
- FDA event ID
- 93291
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Oct 2023
- FDA classified
- 14 Nov 2023
- Reported
- 22 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Imaging Equipment
Timeline
| 9 Oct 2023 | Recall initiated by company | |
| 14 Nov 2023 | Classified by FDA | +36 days |
| 22 Nov 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
Product as listed by the FDA
Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
Where it was distributed
Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan
Questions about this recall
Why was it recalled?
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
Which lots are affected?
UDI-DI: (01)00884838059450 Serial Numbers: Serial Number 7362 75114 7441 7449 7996 7104 7333 7991 7497 7762 7254 7373 7674 7783 7971 7802 7385 7840 7353 750010 75107 8007 7990 7716 7689 7618 75045 7442 750017
Where was it sold?
Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 93291This product is part of a recall event; the main page for the event is Brilliance CT Big Bore recalled by Philips North America.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Brilliance CT Big Bore recalled by Philips North America | Philips North America | Labeling Errors | Nationwide | |
| CLASS II | Big Bore RT recalled by Philips North America | Philips North America | Labeling Errors | Nationwide |
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