FDA recall Z-0727-2021

PHILIPS HOME HEALTHCARE SOLUTION · Class II · device

Product

ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

Reason for recall

After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2020-12-08
Report date: 2021-02-03
Termination date: 2024-06-21
Voluntary/Mandated: FDA Mandated
Location: Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0727-2021