Recall Z-0905-2019 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems Nederlands
Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imaging System
| Date | Feb 22, 2019 (initiated Dec 21, 2018) |
| Status | Terminated |
| 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | Urgent Medical Device Correction notification letters dated December 2018 were sent to customers. |
| Quantity | 11226 total |
| Distribution | U.S. Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043147 | ACHIEVA FAMILY Philips Medical Systems North America Co., Feb 15, 2005 |