FDA Device recall Z-2601-2025
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332
- 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. IQon Spectral CT, Model Number: 728332 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-2601-2025 |
| 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. IQon Spectral CT, Model Number: 728332.
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: 728332; UDI-DI: 00884838059542; Serial Numbers: 860088, 860023, 860077, 860086, 60019, 860152, 860215,…1. Model Number: 728332; UDI-DI: 00884838059542; Serial Numbers: 860088, 860023, 860077, 860086, 60019, 860152, 860215, 60031, 60123, 60129, 60152, 860011, 860049, 860019, 860008, 860030, 860025, 860009, 860022, 860013, 860024, 860020, 860036, 860041, 860046, 860055, 860058, 860054, 860073, 860065, 860070, 860072, 860066, 860103, 860076, 860085, 860095, 860102, 860101, 860104, 860175, 860136, 860117, 860120, 860121, 860124, 860125, 860191, 860131, 860150, 860164, 60041, 860207, 60003, 860157, 860167, 860158, 860196, 60012, 860176, 860185, 860168, 860179, 860194, 60010, 60013, 60007, 60001, 395003, 860209, 860208, 60036, 60030, 60027, 60054, 60055, 60053, 60058, 60079, 395005, 60145. |
|---|
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-2601-2025%22
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