Recall Z-0805-05 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Laerdal Medical Corporation
LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000 and 4000 series defibrillators and Philips Medical Systems CodeMaster 100 and XL series defibrillators. The Adapter Cable is supplied to customers as an independent accessory and is sold in a clear poly bag with a white stick on label tha
| Date | May 12, 2005 (initiated Apr 29, 2005) |
| Status | Terminated |
| Reason | Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator. |
| Root cause | Other |
| Action | Press release issued 4/28/2005. Letters to customers issued 4/29/2005. The letters sent via First Class Mail and are flagged: "URGENT RECALL NOTIFICATION". Customers instructed to order alternative electrode/cable solutions from Philips Medical Systems; discontinue clinical use of Adapter Cables; discard cables or use them for training purposes only. |
| Quantity | At least 3,019 units sold in the U.S. |
| Distribution | Nationwide and worldwide distribution. Laerdal Wappingers Falls, NY is only addressing the nationwide distribution. Laerdal Medical Corp. HQ in Norway is addressing worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.