FDA recall Z-0388-2018

Philips Medical Systems (Cleveland) Inc · Class II · device

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.

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

Key facts

Status
Terminated
Initiation date
2017-11-10
Report date
2018-01-24
Termination date
2020-11-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cleveland, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0388-2018