FDA Device recall Z-1316-2026
IQon Spectral CT
- FDA Device
- Class II
- ongoing
- Published 2026-02-18
On 2026-02-18 the FDA classified a Class II recall of IQon Spectral CT by Philips North America, citing as part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1316-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-07 |
| Published | 2026-02-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips North America |
| Distribution | US |
Product
IQon Spectral CT; Product Code (REF): 728332;
Reason
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Identifiers
| code_info | Product Code (REF): 728332; UDI-DI: 00884838059542; Serial Numbers: 60128, 60141, 60151, 60161, 60171, 60181, 60129, 60…Product Code (REF): 728332; UDI-DI: 00884838059542; Serial Numbers: 60128, 60141, 60151, 60161, 60171, 60181, 60129, 60142, 60152, 60162, 60172, 60182, 60130, 60143, 60153, 60163, 60173, 60132, 60144, 60154, 60164, 60174, 60133, 60145, 60155, 60165, 60175, 60134, 60146, 60156, 60166, 60176, 60136, 60147, 60157, 60167, 60177, 60137, 60148, 60158, 60168, 60178, 60138, 60149, 60159, 60169, 60179, 60139, 60150, 60160, 60170, 60180, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1316-2026%22
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