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.
This recall has been terminated (originally issued November 10, 2017).
- Recall Initiated
- November 10, 2017
- Terminated
- November 5, 2020
- Recall Number
- Z-0388-2018
- Quantity
- 13
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Philips has identified that 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, which may have a potential for harm.
Distribution
Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
Lot / Code Info
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, UDI: (01)00884838059474(21)100787; 100790, UDI: (01)00884838059474(21)100790; 100791, UDI: (01)00884838059474(21)100791; and 100794, UDI: (01)00884838059474(21)1007.
Root Cause
Under Investigation by firm
Action Taken
An Urgent - Field Safety Notice Medical Device Correction letter, dated November 1, 2017, was sent to customers. The letter identified the affected device, described the issue, and discussed the hazard involved. Users are to cease use immediately and contact their Philips Field Service Engineer, if any unusual noises are heard within the gantry, or if the patient support tabletop is in free float. Philips Field Service Engineers will correct the system by replacing the affected fasteners. If further info or support concerning this issue is needed, customers can contact their local Philips rep or the Customer Care Solutions Center at 1-800-722-9377.