FDA Device recall Z-3023-2020
ProxiDiagnost N90
- FDA Device
- Class II
- terminated
- Published 2020-10-07
On 2020-10-07 the FDA classified a Class II recall of ProxiDiagnost N90 by Philips North America, citing unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3023-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-20 |
| Published | 2020-10-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | n/a |
Product
ProxiDiagnost N90
Reason
Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
Identifiers
| code_info | All ProxiDiagnost N90 systems are affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3023-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.