Drug recall
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
FDA recall event 92720 · Class II · Philips North America
Key facts
| Event ID | 92720 |
|---|---|
| Recall numbers | Z-2395-2023, Z-2396-2023, Z-2397-2023 |
| Recalling firm | Philips North America |
| Product type | Devices |
| Products | Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106, Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X), MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system. |
| Initiation date | Jun 12, 2023 |
| Report date | Aug 16, 2023 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 3006648320 |
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: