Drug recall
Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Imaging System
FDA recall event 82038 · Class II · Philips Medical Systems Nederlands
Key facts
| Event ID | 82038 |
|---|---|
| Recall numbers | Z-0869-2019, Z-0870-2019, Z-0871-2019, Z-0872-2019, Z-0873-2019, Z-0874-2019, Z-0875-2019, Z-0876-2019, Z-0877-2019, Z-0878-2019, Z-0879-2019, Z-0880-2019 and 52 more |
| Recalling firm | Philips Medical Systems Nederlands |
| Product type | Devices |
| Products | Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Imaging System, Achieva 1.5T Conversion, Model Number 781346. Nuclear Magnetic Resonance Imaging System, Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging System, Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System, Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System and 59 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. |
| Initiation date | Dec 21, 2018 |
| Report date | Mar 6, 2019 |
| Termination date | Nov 19, 2020 |
| 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: