Philips Brilliance 64 CT System Recalled for Software Defects
Philips is recalling 1,765 Brilliance 64 CT systems worldwide due to software defects that may cause operational errors, image issues, or misdiagnosis.
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: The recall is classified as FDA Class II. The hazard involves a risk of misdiagnosis due to software defects, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling 1,765 units of the Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. The affected devices are distributed worldwide, including in the United States, Puerto Rico, and numerous international markets.
The recall is due to multiple software defects that could impact the performance or reliability of the system. These impacts include error messages that prevent operation, incorrect scan regions, couch movement failure, inaccurate CTDI reporting, image artifacts, and lost images. The source text notes that there is a risk of misdiagnosis associated with these defects.
Healthcare facilities and users should contact Philips Medical Systems for further information regarding the recall and corrective actions. The specific serial numbers affected are listed in the official recall documentation.
The recalled product
- Product
- Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. 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…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 1,765
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)
- Serial numbers: 4001
- 4020
- 4021
- 9030
- 9033
- 9040
- 9041
- 9048
- 9049
- 9062
- 9074
- 9083
- 9093
- 9105
- 9106
- 9107
- 9108
- 9112
- 9123
- 9126
Distribution
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