FDA Device recall Z-2417-2021
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
- FDA Device
- Class II
- completed
- Published 2021-09-15
On 2021-09-15 the FDA classified a Class II recall of Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device by Philips North America, citing when using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2417-2021 |
| Classification | Class II |
| Status | completed |
| Initiated | 2021-08-11 |
| Published | 2021-09-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
Reason
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Identifiers
| code_info | Serial Number Unique Device Identifier (UDI#) Model: 781342 71352 N/A 71426 N/A 71977 (01)00884838055339(21)71977 85020…Serial Number Unique Device Identifier (UDI#) Model: 781342 71352 N/A 71426 N/A 71977 (01)00884838055339(21)71977 85020 (01)00884838055339(21)85020 85106 (01)00884838055339(21)85106 71011 N/A 71152 N/A 71526 N/A 71433 (01)00884838055339(21)71433 71710 (01)00884838055339(21)71710 71817 (01)00884838055339(21)71817 71812 (01)00884838055339(21)71812 71403 (01)00884838055339(21)71403 71311 N/A 71345 N/A 71392 N/A 71395 N/A 71628 N/A 71723 (01)00884838055339(21)71723 85393 (01)00884838055339(21)85393 71042 N/A 71101 N/A 71168 N/A 71179 N/A 71178 N/A 71214 N/A 71252 N/A 71313 N/A 71342 N/A 71328 N/A 71309 N/A 71419 N/A 71453 N/A 71555 N/A 71557 N/A 71550 N/A 71551 N/A 71693 (01)00884838055339(21)71693 71674 (01)00884838055339(21)71674 71733 (01)00884838055339(21)71733 71859 (01)00884838055339(21)71859 71949 (01)00884838055339(21)71949 71993 (01)00884838055339(21)71993 71994 (01)00884838055339(21)71994 85045 (01)00884838055339(21)85045 85036 (01)00884838055339(21)85036 85155 (01)00884838055339 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2417-2021%22
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