FDA Device recall Z-3043-2026
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232
- FDA Device
- Class II
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class II recall of Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232 by Philips North America, citing philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3043-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-07 |
| Published | 2026-09-09 |
| Last updated | 2026-09-15 05:30 UTC |
| Company | Philips North America |
| Distribution | n/a |
Product
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
Reason
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Identifiers
| code_info | Brilliance CT 64 Channel UDI (01)00884838083325. Brilliance CT 64 Upgrades UDI N/A. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-15 05:30 UTC. Current status: ongoing.
Other recalls by Philips North America
- Ingenia 3.0T and 3.0T CX
FDA Device · Class II · 2026-10-07 · Philips North America - MR 7700
FDA Device · Class II · 2026-10-07 · Philips North America - SmartPath to MR 7700
FDA Device · Class II · 2026-10-07 · Philips North America - Upgrade to MR 7700
FDA Device · Class II · 2026-10-07 · Philips North America - Upgrade dStream
FDA Device · Class II · 2026-10-07 · Philips North America
All Philips North America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3043-2026%22
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