Recall Z-0321-06 ยท MLN Electrode, Electrocardiograph, Multi-Function
Philips Medical Systems
HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads Model M3717A
| Date | Dec 23, 2005 (initiated Nov 18, 2005) |
| Status | Terminated |
| Reason | The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector |
| Root cause | Other |
| Action | Philips Medical sent the recall notification letter 11/30/05 via FedEx |
| Quantity | 253 CASES (5/CS) |
| Distribution | Nationwide Foreign: Australia, Canada, France, germany, Spain,, Sweden, Switzerland, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003228 | K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A Katecho, Inc., Dec 14, 2000 |