Philips CT Scanner Recall for Dose Limit Software Defect
Philips is recalling eight Brilliance 64 and Ingenuity CT scanners because a software update allows users to disable dose alerts, potentially permitting scans that exceed safety limits.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural software defect that allows users to bypass safety limits, potentially leading to significant injury through excessive radiation exposure.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling eight units of the Brilliance 64 and Ingenuity CT whole body Computed Tomography X-Ray Systems. The recall affects specific system codes and serial numbers distributed in the United States (including Indiana and Ohio) as well as Australia, Belgium, China, Israel, and Sweden.
The recall is due to a software design defect in version 4.0.0xx379. This version does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanning, a restriction that was present in previous versions. While the system includes a Dose Check feature that provides notifications and alerts, users can disable this check, creating a risk of excessive radiation exposure.
Healthcare facilities and users of these specific CT scanners should contact Philips Medical Systems for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and displ
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 8
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 (9)
- System Code # 728231
- Serial #s: 91003
- 95157
- 9654
- 95130
- and 95504 System Code # 728326
- Serial #s: 300010
- 300030
- and 300018
Distribution
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