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Terminated

ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

FDA Recall Z-0727-2021 · Posted 2021-01-28

Recalling FirmPHILIPS HOME HEALTHCARE SOLUTION
Recall StatusTerminated
Product CodeOWB
Date Initiated2020-12-08
Date Terminated2024-06-21
Product Quantity91

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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K173433ProxiDiagnost N90Philips Medical Systems Dmc GmbH · 2018-02-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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