Z-0240-2022Class II

ProxiDiagnost N90 is multi-functional general R/F systems

Name: Z-0240-2022 ProxiDiagnost N90 is multi-functional general R/F systems
Creator: Philips Healthcare
Published: 2021-09-22
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-09-22 / Open, Classified / root cause: labeling and UDI

FDA source

Philips Healthcare began a recall of ProxiDiagnost N90 is multi-functional general R/F systems on 2021-09-22. FDA classified it as Class II and gives the reason as "The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0240-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-22
Posted: 2021-11-24
Recalling firm: Philips North America LLC
Product: ProxiDiagnost N90 is multi-functional general R/F systems.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips sent an Electronic Product Radiation Correction letter to inform customers. The letter identified the affected product, problem and actions to be taken. Customers were informed Philips Field Service Engineer will visit their site to check for the required labels and if they are missing, will resolve the issue by applying the required labels. Customers were instructed to complete and return the attached acknowledgment form to Philips DXR via email to [email protected]. For questions contact Customer Care Solutions Center 1-800-722-9377.
Quantity in commerce: 281 in total
Distribution: US Nationwide Distribution
Product codes and lots: ProxiDiagnost N90

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0240-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0239-2022	Class II	Ongoing	FDA Mandated	2021-12-01	2021-11-24
Z-0240-2022	Class II	Ongoing	FDA Mandated	2021-12-01	2021-11-24
Z-0241-2022	Class II	Ongoing	FDA Mandated	2021-12-01	2021-11-24

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)