Recall Z-1587-2023— Philips North America

Name: FDA recall Z-1587-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-03

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2023-03-03. It names one FDA 510(k) clearance: K173433. Product: ProxiDiagnost N90 R.1.0. Reason: Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA)..

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2023-03-03
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 R.1.0

Reason for recall

Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).

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