Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiati
Summary
The FDA issued a Class II for Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT sc by Philips North America Llc. Reason: 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 seco.
Details
Source
Device Recall
External ID
Z-0293-2024
Action Date
2023-11-22
Status
Ongoing
Category
device
Product Description
Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.
Lot/Code Info: UDI-DI: (01)00884838059450 Serial Numbers: 760012 7742 75043 76137 76005 7830 76202 76134 76038 7871 7825
Quantity Affected: 11 units
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.
Distribution
Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-09
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America Llc has 302 FDA actions in our database, including 302 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America Llc have FDA actions?
Philips North America Llc has 302 FDA actions in our database, including 302 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0293-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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