FDA Device recall Z-1462-2024
Agfa DX-D 100 system-Digital Radiography mobile X-ray System
- FDA Device
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of Agfa DX-D 100 system-Digital Radiography mobile X-ray System by Agfa N V, citing steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1462-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-23 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Agfa N V |
| Distribution | US |
Product
Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 0400
Reason
Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury
Identifiers
| code_info | UDI: 5414904272725YG US Serial Numbers: Serial Number A5411001002 A5411001003 A5411001005 A5411001033 A5411001034 A5411…UDI: 5414904272725YG US Serial Numbers: Serial Number A5411001002 A5411001003 A5411001005 A5411001033 A5411001034 A5411001035 A5411001036 A5411001037 A5411001038 A5411001039 A5411001064 A5411001065 A5411001066 A5411001067 A5411001068 A5411001069 A5411001073 A5411001080 A5411001081 A5411001087 A5411001089 A5411001090 A5411001097 A5411001098 A5411001099 A5411001105 A5411001110 A5411001112 A5411001149 A5411001151 A5411001152 A5411001162 A5411001163 A5411001164 A5411001165 A5411001174 A5411001175 A5411001176 A5411001177 A5411001201 A5411002007 A5411002023 A5411002024 A5411002025 A5411002029 A5411002030 A5411002031 A5411002032 A5411002033 A5411002047 A5411002048 A5411002049 A5411002051 A5411002052 A5411002053 A5411002054 A5411002058 A5411002059 A5411002060 A5411002061 A5411002063 A5411002064 A5411002065 A5411002070 A5411002071 A5411002072 A5411002073 A5411002074 A5411002076 A5411002078 A5411002082 A5411002083 A5411002084 A5411002085 A5411002128 A5411002129 A5411002130 A5411002131 A541100214 |
|---|
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-1462-2024%22
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