Philips Big Bore RT CT Scanner Defect May Cause Incorrect Treatment Planning
A software defect in Philips Big Bore RT CT scanners may cause incorrect coordinates in radiation therapy planning systems, affecting 56 units distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device that poses significant risk of harm if the defect occurs (incorrect radiation therapy planning and diagnosis). No illnesses, injuries, or deaths have been reported. The hazard represents a risk-of-harm scenario where injury has not yet been documented, meeting the criteria for a High (3) severity rating.
Plain-English summary
Philips has recalled 56 Big Bore RT CT scanners (Model 728242, software version V4.8.0.10421) due to a defect in off-set reconstruction that may produce inaccurate image positioning and coordinates.
For radiation oncology users, when using image fusion during treatment planning, the defect may cause a shift in the contouring area between primary and secondary image sets. This can result in incorrect coordinates being sent to the treatment planning system, potentially leading to improper radiation therapy planning and incorrect early treatment delivery.
For radiology users, the defect may result in inaccurate positioning information after multiple acquisitions, which could lead to incorrect diagnosis and treatment decisions.
Users should contact Philips for guidance on available software updates or device modifications. The recall affects 56 specific serial numbers distributed nationwide and in multiple countries including Canada, Mexico, and several European nations.
The recalled product
- Product
- Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
- Manufacturer
- Philips North America Llc
- Affected units
- 56
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: (01)00884838095168 Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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