FDA Device recall Z-1072-2024
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
- FDA Device
- Class II
- ongoing
- Published 2024-02-21
On 2024-02-21 the FDA classified a Class II recall of ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110 by Philips North America, citing 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 pati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1072-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-15 |
| Published | 2024-02-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
Reason
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)
Identifiers
| code_info | UDI: (1) 00884838085619 (2) 00884838103221 UDI: (1) 00884838085619 (2) 00884838103221 Serial Numbers US: (1) 10001064…UDI: (1) 00884838085619 (2) 00884838103221 UDI: (1) 00884838085619 (2) 00884838103221 Serial Numbers US: (1) 10001064 10001065 10001066 10001067 10001068 10001069 10001070 10001072 10001073 10001074 10001075 10001076 10001077 10001078 10001079 10001084 10001085 10001086 10001087 10001088 10001089 10001090 10001091 10001092 10001093 10001096 10001098 10001099 10001100 10001101 10001102 10001104 10001105 10001107 10001108 10001109 10001110 10001111 10001112 10001113 10001114 10001116 10001117 10001120 10001121 10001125 10001128 10001129 10001130 10001132 10001135 10001136 10001137 10001138 10001139 10001140 10001141 10001142 10001143 10001144 10001145 10001149 10001150 10001152 10001153 10001157 10001158 10001159 10001160 10001161 1000116 (2) 20000026 20000061 20000062 20000068 20000078 20000079 20000086 SN10001002 SN10001003 SN10001004 SN18000002 SN18000006 SN18000013 SN18000018 SN18000024 SN19000007 SN19000017 Serial Numbers OUS: Serial Number 10000042 SN10001000 SN10001006 10001055 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1072-2024%22
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