FDA Device recall Z-2602-2025
Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324
- FDA Device
- Class II
- ongoing
- Published 2025-10-01
On 2025-10-01 the FDA classified a Class II recall of Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324 by Philips North America, citing the patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2602-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-13 |
| Published | 2025-10-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
Reason
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Identifiers
| code_info | 1. Model Number: 728324; UDI-DI: 00884838059863; Serial Numbers: 336821, 337127, 336823, 336824, 336828, 336817, 336952…1. Model Number: 728324; UDI-DI: 00884838059863; Serial Numbers: 336821, 337127, 336823, 336824, 336828, 336817, 336952, 336826, 336847, 336857, 336876, 336894, 336948, 336936, 336947, 337012, 337074, 337090, 337116, 337136, 345016, 345032, 345099, 345104. |
|---|
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-2602-2025%22
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