FDA Device recall Z-2597-2025
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243…
- 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. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243… 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-2597-2025 |
| 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. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
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: 728242; UDI-DI: 00884838095168; Serial Number: 766018. 2. Model Number: 728243; UDI-DI: N/A; Serial…1. Model Number: 728242; UDI-DI: 00884838095168; Serial Number: 766018. 2. Model Number: 728243; UDI-DI: N/A; Serial Numbers: 7179, 7238, 7273, 7418, 7467, 7608, 7634, 7618, 7801, 7925, 75111, 75045, 75119, 75035, 75132, 750019, 76023. 3. Model Number: 728244; UDI-DI: 00884838059450; Serial Numbers: 7271, 7979, 76234, 750003, 7878, 76054, 760019, 76135, 76230, 76147, 76171, 760057, 760058, 76270, 760075. |
|---|
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-2597-2025%22
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