Z-1073-2024Class II

ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150

Name: Z-1073-2024 ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
Creator: Philips North America
Published: 2023-12-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-12-15 / Open, Classified / root cause: software

FDA source

Philips North America began a recall of ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150 on 2023-12-15. FDA classified it as Class II and gives the reason as "Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1073-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-15
Posted: 2024-02-09
Recalling firm: Philips North America LLC
Product: ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)
Root cause tag: software
FDA root cause: Software design
Action: ***UPDATE*** 19 ProxiDiagnost N90 Systems (18 US & 1 OUS) added to scope as these systems were produced prior to implementation of the solution in forward production. The newly identified consignees notified on 20 Nov 2024*** Philips issued URGENT Medical Device Correction ProxiDiagnost N90 1.1 and ProxiDiagnost Upgrade on 12/15/2024. Letter states reason for recall, health risk and action to take: For Issues 1 and 2: " To avoid previous patient data from being represented as current patient data, ensure all images have been exported from the previous RAD exam before starting a new examination. " Correct images will be square shape and wrong images can be recognized by a different patient anatomy and rectangular shape. If you identify a wrong image, flag the incorrect images and only export not flagged images for the current examination to PACS (See figure. Refer to Appendix A for specific details regarding the other issue descriptions and advice on actions to be taken. " Customers can continue using affected systems in accordance with the intended use. " Circulate this notice to all users of this device so that they are aware of the issue. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the URGENT Medical Device Correction Notice, understanding of the issue, and required actions to be taken. A Field Service Engineer (FSE) will contact you to schedule a time to visit your site and install the software upgrade to resolve the issues (Reference FCO70600110). Philips plans to start implementing the solution in Q2 2024. The software upgrade will also include software enhancements to improve clinical experience. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in commerce: 20 units: 16 units US; 4 units OUS
Distribution: Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand
Product codes and lots: UDI: N/A Serial Numbers US: 4 5 6 7 8 9 11 12 13 14 17 18 61 692222229 692222254 692222263 Serial Numbers OUS: 53 56 65 692222227

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1073-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1072-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-09
Z-1073-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-09

Product code JAA

K212837Class IIProxiDiagnost N90Philips Medical Systems Dmc GmbH / cleared 2021-09-21

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)