FDA recall Z-2009-2019
Philips Medical Systems (Cleveland) Inc · Class II · device
Product
BrightView SPECT, Model Number 882480
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-2009-2019