NT Intera Magnetic Resonance Image System
FDA device recall Z-1488-04 · posted 2004-09-29 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Reason for recall
- Potential for patient burn
- Action taken
- On 8/20/04 the firm issued a letter, via certified return receipt. The letter warned of the potential for patient discomfort and burns. An addendum providing additional information regarding cable positioning was included with the letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRP
- Quantity affected
- 156 devices
- Distribution
- Units distributed to medial facilities and hospitals throughout the U.S.
- Date initiated
- 2004-08-20
- Date posted
- 2004-09-29
- Date terminated
- 2006-02-09
- 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 INTERA (R7.5) (K001796) | Philips Medical Systems North America, Inc. | 2000-09-06 |