FDA Device recall Z-0810-2024
Ingenia Ambition X, Model No. 782109
- FDA Device
- Class III
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class III recall of Ingenia Ambition X, Model No. 782109 by Philips North America, citing an incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0810-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-12-29 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Ingenia Ambition X, Model No. 782109
Reason
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
Identifiers
| code_info | Model No. 782109 UDI-DI 00884838098350 Serial Number 47785 |
|---|
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-0810-2024%22
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