Philips Brilliance 64 CT Systems Recalled for Software Error
Philips Medical Systems is recalling 184 Brilliance 64 CT systems worldwide due to a software error involving the filament on timer.
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, and the source text does not report any illnesses or injuries, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 184 units of the Brilliance 64 728231 Computed Tomography X-ray systems. These devices are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. The recall is due to a software error associated with the filament on timer.
The affected units were distributed worldwide, including in the United States and numerous international locations. The specific distribution pattern includes the US and countries such as Australia, Brazil, Canada, China, Germany, Japan, and the United Kingdom.
Consumers and healthcare facilities should contact Philips Medical Systems for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- Brilliance 64 728231 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. These devices may include signal analysis and display equipment, patient and…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 184
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)
- 4001
- 4016
- 9056
- 9071
- 9074
- 9099
- 9112
- 9134
- 9194
- 9251
- 9280
- 9367
- 9515
- 9529
- 9538
- 9541
- 9548
- 9549
- 9554
- 9559
Distribution
Part of a larger recall action
This product is one of 5 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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