Recall Z-0727-2021— PHILIPS HOME HEALTHCARE SOLUTION

Name: FDA recall Z-0727-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-08

Class II · Terminated

Class II FDA medical device recall by PHILIPS HOME HEALTHCARE SOLUTION, initiated 2020-12-08, terminated 2024-06-21. It names one FDA 510(k) clearance: K173433. Product: ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system. Reason: 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..

Recalling firm: PHILIPS HOME HEALTHCARE SOLUTION
Classification: Class II
Status: Terminated
Initiated: 2020-12-08
Terminated: 2024-06-21
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K173433 — ProxiDiagnost N90Philips Medical Systems Dmc GmbH·cleared 2018-02-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.