Gyroscan MRI
FDA device recall Z-0981-2007 · posted 2007-06-27 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 293 units
- Distribution
- Units were distributed throughout the US to 1,078 hospitals and medical centers.
- Date initiated
- 2007-04-30
- Date posted
- 2007-06-27
- Date terminated
- 2011-09-21
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT (K945945) | Philips Medical Systems North America, Inc. | 1995-12-22 |