Z-3023-2020Class II

ProxiDiagnost N90

Name: Z-3023-2020 ProxiDiagnost N90
Creator: Philips North America, LLC
Published: 2019-11-20
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-11-20 / Terminated

FDA source

Philips North America, LLC began a recall of ProxiDiagnost N90 on 2019-11-20. FDA classified it as Class II and gives the reason as "Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3023-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-20
Posted: 2020-09-30
Terminated: 2024-04-04
Recalling firm: Philips North America LLC
Product: ProxiDiagnost N90
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
FDA root cause: Radiation Control for Health and Safety Act
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.
Quantity in commerce: 71
Distribution: United States
Product codes and lots: All ProxiDiagnost N90 systems are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3023-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3023-2020	Class II	Terminated	FDA Mandated	2020-10-07	2020-09-30

Product code OWB

K173433Class IIProxiDiagnost N90Philips Medical Systems Dmc GmbH / cleared 2018-02-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)