Recall Z-1488-04 ยท KRP Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal
Philips Medical Systems Sales & Service Region No. America
NT Intera Magnetic Resonance Image System
| Date | Sep 29, 2004 (initiated Aug 20, 2004) |
| Status | Terminated |
| Reason | Potential for patient burn |
| Root cause | Other |
| Action | 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. |
| Quantity | 156 devices |
| Distribution | Units distributed to medial facilities and hospitals throughout the U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001796 | GYROSCAN INTERA (R7.5) Philips Medical Systems North America, Inc., Sep 6, 2000 |