Drug recall
Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR…
FDA recall event 82610 · Class II · Philips Medical Systems Nederlands
Key facts
| Event ID | 82610 |
|---|---|
| Recall numbers | Z-1240-2019 |
| Recalling firm | Philips Medical Systems Nederlands |
| Product type | Devices |
| Products | Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electrical shocks to personnel servicing the MED, MDD or connected cabling. |
| Initiation date | Mar 25, 2019 |
| Report date | May 8, 2019 |
| Termination date | Jun 4, 2020 |
| City | Best |
| Country | Netherlands |
| FEI number | 3002807880 |
At a glance
- 1–9 Products in this recall
- 1–9 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: