Philips CT Systems Recalled for Inverted Scan Position Software Defect
Philips is recalling 424 CT systems worldwide because a software defect inverts the sign of the longitudinal position for some scans.
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 2/5 (Moderate).
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. The source text describes a software defect affecting scan position indication but does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 424 Computed Tomography (CT) X-ray systems, including Brilliance and Ingenuity models, due to a software defect. The defect causes the sign indication of the longitudinal position of some types of scans to be inverted.
The affected units were distributed nationwide in the United States and to numerous countries worldwide. Specific serial numbers for the Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, and Ingenuity CT models are listed in the official recall documentation.
Healthcare facilities should contact Philips Medical Systems to verify if their equipment is affected and to obtain the necessary software correction. This recall addresses a software error that may impact the accuracy of scan positioning data.
The recalled product
- Product
- Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 424
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)
- Brilliance iCT: 728306
- Serial Numbers: 85012
- 85013
- 85014
- 100029
- 100038
- 100040
- 100053
- 100058
- 100094
- 100099
- 100133
- 100140
- 100162
- 100178
- 100236
- 100244
- 100373
- 100399
- 100408
Distribution
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