FDA recall Z-0519-2018
Philips Medical Systems (Cleveland) Inc · Class II · device
Product
Philips Ingenuity Core computed tomography x-ray system
Reason for recall
Numerous issues related to software Brilliance iCT 4.1.6 software version.
Distribution
26 US Govt accounts
Key facts
- Status
- Terminated
- Initiation date
- 2017-10-06
- Report date
- 2018-02-14
- Termination date
- 2019-07-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Cleveland, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0519-2018