Drug recall
Enterprise 1.5T, Model Number: 781145;
FDA recall event 96728 · Class II · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Key facts
| Event ID | 96728 |
|---|---|
| Recall numbers | Z-1770-2025, Z-1771-2025, Z-1772-2025, Z-1773-2025, Z-1774-2025, Z-1775-2025, Z-1776-2025, Z-1777-2025, Z-1778-2025, Z-1779-2025, Z-1780-2025, Z-1781-2025 and 2 more |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Product type | Devices |
| Products | Enterprise 1.5T, Model Number: 781145;, Intera 0.5T Standard, Model Number: 781101;, Intera 1.0T Omni/Stellar, Model Number: 781102;, Intera 1.0T Power/Pulsar, Model Number: 781103;, Intera 1.5T Explorer/Nova Dual, Model Number: 781108; and 9 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient… |
| Initiation date | Mar 24, 2025 |
| Report date | May 21, 2025 |
| City | Best |
| Country | Netherlands |
| FEI number | 3002807880 |
At a glance
- 10–99 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: