FDA Device recall Z-2283-2023
Allura Xper FD10 and FD20
- FDA Device
- Class II
- ongoing
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of Allura Xper FD10 and FD20 by Philips Medical Systems Nederland B V, citing the bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2283-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-12 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Allura Xper FD10 and FD20. X-ray Imaging System.
Reason
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
Identifiers
| code_info | Model No.: 722010, 722012, 722022, 722023, 722026, 722028, 722033, 722035; UDI-DI: (01)00884838054189(21), (01)00884838…Model No.: 722010, 722012, 722022, 722023, 722026, 722028, 722033, 722035; UDI-DI: (01)00884838054189(21), (01)00884838054202(21), (01)00884838054240(21), (01)00884838059054(21), (01)00884838059085(21), (01)00884838059191(10), (01)00884838059283(10); System Equipment Number: 52756450, 53152280, 53339159, 53341109, 53362649, 53367108, 53417434, 53499745, 53532256, 53544735, 53564038, 53758475, 53760903, 53861955, 53882172, 53925133, 53953857, 53954111, 53977885, 54228786, 54367887, 54439862, 54439913, 54635472, 54650173, 54650176, 54803862, 54812217, 54853203, 54861346, 54877925, 54972306, 55063750, 55102809, 55103418, 55126283, 55137722, 55139337, 55236546, 55270907, 55289325, 55310609, 55366802, 55378038, 55379838, 55416634, 55423934, 55424653, 55431632, 55432120, 55624201, 55651562, 55835022, 56012278, 56034732, 56077694, 56131358, 56282614, 56310022, 56552489, 56711453, 56787342, 56889792, 56898414, 56898439, 56919586, 56925642, 56931775, 56932067, 56933642, 56983248, 57319691, 5734 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2283-2023%22
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