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Terminated

ProxiDiagnost N90

FDA Recall Z-3023-2020 · Posted None

Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeOWB
Date Initiated2019-11-20
Date Terminated2024-04-04
Product Quantity71

Reason for Recall

Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.

Firm Action

Philips sent an Urgent Field Safety Notice dated August 5, 2020 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Philips plans to correct the defect at no cost to customers by implementing a field correction involving the installation of a software update. A Philips Field Service Engineers will schedule an appointment with customers to install the software update.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

United States

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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