Recall Z-3023-2020— Philips North America, LLC

Name: FDA recall Z-3023-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-20

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2019-11-20, terminated 2024-04-04. It names one FDA 510(k) clearance: K173433. Product: ProxiDiagnost N90. Reason: Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-11-20
Terminated: 2024-04-04
Firm location: Andover, 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

Reason for recall

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

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