FDA Device recall Z-1417-2023
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
- FDA Device
- Class II
- ongoing
- Published 2023-04-26
On 2023-04-26 the FDA classified a Class II recall of 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1 by Philips Medical Systems Nederland B V, citing there are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1417-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-20 |
| Published | 2023-04-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
Reason
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
Identifiers
| code_info | UDI: (01)00884838059276 2D Perfusion with Allura Xper or Azurion model number: 722003, 722006, 722008, 722010, 722012,…UDI: (01)00884838059276 2D Perfusion with Allura Xper or Azurion model number: 722003, 722006, 722008, 722010, 722012, 722013, 722020, 722023, 722026, 722027 722028, 722029, 722035, 722038, 722039, 722058, 722059, 722064, 722067 722068, 722078, 722079, 722223, 722224, 722225, 722226, 722227 and 722228. Software License Keys: 459801071511 sw key 2D Perfusion (IW) 459800240601 sw key 2D Perfusion (XV) |
|---|
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-1417-2023%22
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