FDA Device recall Z-3195-2024
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structu…
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structu… by Philips North America, citing integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially bl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3195-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-03 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782103
Reason
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Identifiers
| code_info | UDI-DI: (01)00884838098299(21) Serial Numbers: 85625 85626 85628 85630 85633 85637 85638 85641 85642 85646 85650 85652…UDI-DI: (01)00884838098299(21) Serial Numbers: 85625 85626 85628 85630 85633 85637 85638 85641 85642 85646 85650 85652 85653 85654 85656 85657 85658 85659 85660 85662 85664 85666 85667 85668 85672 85674 85682 85683 85686 85692 85696 85701 85713 |
|---|
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-3195-2024%22
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