Philips Brilliance 64 CT System Recalled for Image Labeling Error
Philips is recalling 582 Brilliance 64 CT systems because images may be incorrectly labeled as having phase tolerance applied when it was not.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error that could lead to misinterpretation of images, which fits the criteria for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 582 Brilliance 64 Model # 728231 computed tomography x-ray systems. The recall is due to a software issue where, during cardiac step and shoot acquisitions with phase tolerance selected, images may be labeled as if phase tolerance had been applied when it had not actually been applied.
The affected systems were distributed worldwide, including the United States, Puerto Rico, Canada, Mexico, and numerous other countries. The recall notice does not specify a date range for the distribution or the specific serial numbers affected beyond the provided list.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that the defect could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Brilliance 64 Model # 728231, computed tomography x-ray system
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 582
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 (20)
- System Serial Number 335
- 338
- 1897
- 4001
- 4003
- 4016
- 4021
- 9009
- 9029-9030
- 9033
- 9035
- 9038
- 9040
- 9045
- 9047
- 9048
- 9052
- 9054
- 9056
- 9058
Distribution
Part of a larger recall action
This product is one of 9 recalled by Philips Medical Systems (Cleveland) Inc 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.
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