FDA recall Z-2011-2019
Philips Medical Systems (Cleveland) Inc · Class II · device
Product
BrightView XCT , Model Number 882482
Reason for recall
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
Distribution
Worldwide Distribution - US Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2019-06-10
- Report date
- 2019-07-31
- Termination date
- 2020-07-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Cleveland, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2011-2019