Data Foundry

Medical device recalls 2024

ProxiDiagnost upgrade- A Multi-functional general Radiography and… — Class II medical device recall Z-1073-2024

Ongoing recall by Philips North America, reported 2024-02-21, distributed nationwide. Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD

Recall numberZ-1073-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips North America, Cambridge, MA, United States
Recall initiated2023-12-15
Classified2024-02-09
Reported by FDA2024-02-21
DistributedNationwide (US)
Countries outside the USAU, DE, IN, IT, MY, PA, TH
Serial numbers692222227, 692222229, 692222254, 692222263
Model numbers706150

Product

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

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)

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1073-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.