Drug recall
Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
FDA recall event 93787 · Class II · Philips North America
Key facts
| Event ID | 93787 |
|---|---|
| Recall numbers | Z-0945-2024, Z-0946-2024, Z-0947-2024, Z-0948-2024, Z-0949-2024, Z-0950-2024, Z-0951-2024, Z-0952-2024, Z-0953-2024, Z-0954-2024, Z-0955-2024, Z-0956-2024 |
| Recalling firm | Philips North America |
| Product type | Devices |
| Products | Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283., Achieva 1.5T Initial system. Model (REF) Numbers 781178., Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296., Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345., Achieva XR. Model (REF) Numbers 781153, 781253. and 7 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 | Jan 3, 2024 |
| Report date | Feb 7, 2024 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 3006648320 |
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: