Philips CT Scanners Recalled for Image Artifacts During Specific Scans
Philips is recalling 258 CT scanners because artifacts appear on images during threshold-triggered bolus scans using a 0.4-second rotation time.
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, and the hazard involves image artifacts that could affect diagnostic accuracy, but no injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling 258 units of Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, and Brilliance CT 16 (Air) scanners. These are whole-body Computed Tomography (CT) X-ray systems used to produce cross-sectional images of the body.
The recall was initiated because artifacts appear on the Tracker images during threshold-triggered bolus scans when protocols use a Rotation Time of 0.4 seconds. The affected devices were distributed nationwide in the United States, including Puerto Rico, and in numerous countries worldwide.
Healthcare facilities and consumers should contact Philips Medical Systems for instructions on how to address the issue. The recall number is Z-0013-2014.
The recalled product
- Product
- Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 258
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 Code #728243
- Serial #: 7040
- 7083
- 7087
- 7123
- 7124
- 7133
- 7170
- 7178
- 7204
- 7231
- 7273
- 7328
- 7365
- 7370
- 7395
- 7434
- 7467
- 7596
- 7612
Distribution
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