ProxiDiagnost N90- A Multi-functional general Radiography and… — Class II medical device recall Z-1072-2024
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 patient s radiography (RA
| Recall number | Z-1072-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2023-12-15 |
| Classified | 2024-02-09 |
| Reported by FDA | 2024-02-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, DE, IN, IT, MY, PA, TH |
| UPC / GTIN / UDI-DI | 00884838085619, 00884838103221 |
| Serial numbers | 10000042, 10001055, 10001071, 10001082, 10001083, 10001094, 10001095, 10001103, 10001106, 10001115, 10001118, 10001119, 10001123, 10001133, 10001134, 10001147, 10001155, 10001156, SN10001000, SN10001006 |
| Model numbers | 10001055, 10001071, 10001082, 10001083, 10001094, 706110 |
Product
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
Reason for recall
Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s 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-1072-2024. 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.