Drug recall
Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.
FDA recall event 87962 · Class II · Philips North America Llc
Key facts
| Event ID | 87962 |
|---|---|
| Recall numbers | Z-1795-2021, Z-1796-2021 |
| Recalling firm | Philips North America Llc |
| Product type | Devices |
| Products | Ingenia Ambition S - Model Number: 781359 Diagnostic MR system., Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during… |
| Initiation date | Apr 23, 2021 |
| Report date | Jun 16, 2021 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 3016618143 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: