FDA Device recall Z-1756-2024
The Oncology Essentials Package of the Spectral CT imaging system
- FDA Device
- Class II
- ongoing
- Published 2024-05-08
On 2024-05-08 the FDA classified a Class II recall of The Oncology Essentials Package of the Spectral CT imaging system by Philips North America, citing potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1756-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-29 |
| Published | 2024-05-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
The Oncology Essentials Package of the Spectral CT imaging system.
Reason
Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
Identifiers
| code_info | Model No. 728333; UDI: (01)00884838101111(21); Serial No. 10069, 10084, 10169, 10137, 10163, 10196, 10181, 10199, 10210, 10206, 10202, 10139. |
|---|
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-1756-2024%22
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