Philips Brilliance 64 CT Scanner Recalled for Fastener Torque Issues
Philips is recalling one Brilliance 64 CT scanner because certain fasteners may not be torqued to specification, posing a potential risk of harm if parts become loose.
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 involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling one unit of the Brilliance 64 CT scanner (Code 728231, SN # 10655). The device is intended to produce images of the head and body by computer reconstruction of x-ray transmission data.
The recall was initiated because Philips identified that certain fasteners on the device cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
The affected unit was distributed worldwide, including in the United States, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and the United Kingdom. In the US, the device was distributed to four accounts, one of which is military. No specific instructions for consumers are provided in the source text, but the device is a medical device intended for professional use.
The recalled product
- Product
- Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — CT Scanner
- Affected units
- 1
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 (2)
- Code 728231
- SN # 10655
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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