Z-1589-2023Class II

CombiDiagnost R90 R1.1

Name: Z-1589-2023 CombiDiagnost R90 R1.1
Creator: Philips North America
Published: 2023-03-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-03-03 / Open, Classified / root cause: labeling and UDI

FDA source

Philips North America began a recall of CombiDiagnost R90 R1.1 on 2023-03-03. FDA classified it as Class II and gives the reason as "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)". 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-1589-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-03
Posted: 2023-05-15
Recalling firm: Philips North America LLC
Product: CombiDiagnost R90 R1.1
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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).
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 dated March 3, 2023, to affected customers. The letter stated a Philips representative will contact affected customers to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect your system and apply the label if necessary. Philips will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan approved by the Secretary of Health and Human Services. Customers were asked to complete and return the attached acknowledgement form to Philips DXR promptly upon receipt and no later than 30 days from receipt via email to: [email protected]. If you need any further information or support concerning this issue, please contact your local Philips Customer Care Solutions center: 1-800-722-9377 (Reference FCO70600112 for ProxiDiagnost N90 R.1.0 and FCO70900060 for CombiDiagnost R90 R.1.0 and R1.1).
Quantity in commerce: 25 systems in total
Distribution: US Nationwide
Product codes and lots: REF number: 709031 Serial Number: 10001071, 10001072, 10001086, 10001087, 10001114

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1589-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1587-2023	Class II	Ongoing	FDA Mandated	2023-05-24	2023-05-15
Z-1588-2023	Class II	Ongoing	FDA Mandated	2023-05-24	2023-05-15
Z-1589-2023	Class II	Ongoing	FDA Mandated	2023-05-24	2023-05-15

Product code JAA

K203087Class IICombiDiagnost R90Philips Medical Systems Dmc GmbH / cleared 2020-12-03

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)