Z-0391-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2018
- Initiation Date
- November 10, 2017
- Termination Date
- November 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
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 Pattern
Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
Code Information
Code 728323, SN # 320394, UDI: (01)00884838059474(21)320394; 320395, UDI: (01)00884838059474(21)320395; and 336286.