FDA Device recall Z-0894-2019
Achieva 1.5T, Model Number 781178
- FDA Device
- Class II
- terminated
- Published 2019-03-06
On 2019-03-06 the FDA classified a Class II recall of Achieva 1.5T, Model Number 781178 by Philips Medical Systems Nederlands, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0894-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-21 |
| Published | 2019-03-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips Medical Systems Nederlands |
| Distribution | US |
Product
Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System
Reason
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.
Identifiers
| code_info | All systems |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0894-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.