Recall Z-0981-2007 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems North America Co. Phillips
Gyroscan MRI
| Date | Jun 27, 2007 (initiated Apr 30, 2007) |
| Status | Terminated |
| Reason | Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site. |
| Root cause | Other |
| Action | On 4/30/07 Philips sent an Urgent Device Correction letter dated April 25, 2007 via certified mail to customers. The letter advises customers of the issue and that that a representative will visit the sites, inspect and correct the problem if indicated. |
| Quantity | 293 units |
| Distribution | Units were distributed throughout the US to 1,078 hospitals and medical centers. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945945 | GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT Philips Medical Systems North America, Inc., Dec 22, 1995 |