Philips Brilliance iCT Recalled for Potential Fastener Torque Defect
Philips is recalling 13 Brilliance iCT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.
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 'High' severity criteria for potential mechanical failure in a medical device.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 13 units of the Brilliance iCT medical device. The device is intended to produce images of the head and body by computer reconstruction of x-ray transmission data. The recall is due to a manufacturing issue where certain fasteners 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. This condition has a potential for harm to patients or operators. The affected units were distributed worldwide, including in the United States, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. In the US, 4 units were affected, including one military account, while 14 foreign accounts were involved.
Healthcare facilities and users should stop using the affected Brilliance iCT units and contact Philips Medical Systems for further instructions on repair or replacement. The specific serial numbers and UDI codes for the affected units are listed in the official recall documentation.
The recalled product
- Product
- Brilliance iCT 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
- Affected units
- 13
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)
- Code 728306
- SN# 100776
- UDI: (01)00884838059474(21)100776
- 100778
- UDI: (01)00884838059474(21)100778
- 100779
- UDI: (01)00884838059474(21)100779
- 100780
- UDI: (01)00884838059474(21)100780
- 100781
- UDI: (01)00884838059474(21)100781
- 100782
- UDI: (01)00884838059474(21)100782
- 100783
- UDI: (01)00884838059474(21)100783
- 100784
- UDI: (01)00884838059474(21)100784
- 100785
- UDI: (01)00884838059474(21)100785
- 100787
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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