Recall Z-2625-2011 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio Control, Inc.
12-lead ECG Cable Assembly contains the following cable and attachments: Main Cable with Limb Leads: The main cable includes the proximal connector which attaches to the monitor and four incorporated limb lead wires that terminate with ECG electrode snaps. All signals travel through this cable for cardiac monitoring and for 12-lead ECGs. Precordial Lead Attachment: The precordial lead attachment
| Date | Jun 22, 2011 (initiated May 11, 2011) |
| Status | Terminated |
| Reason | The 12-lead ECG cables have experienced premature failures which cause the shielding and conductors to break internally creating ECG noise or "lead off" indications. |
| Root cause | Device Design |
| Action | Physio-Control, Inc. sent an "URGENT-MEDICAL DEVICE ACCESSORY INFORMATION" letter dated May 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The customers were advised to follow the instructions: -Use standard hard paddles or therapy electrodes for ECG monitoring if monitoring cannot be performed using the ECG cable. Refer to Troubleshooting Tips for ECG Monitoring in the LIFEPAK 12 or LIFEPAK 15 Operating Instructions-Monitoring chapter. -Disconnect the ECG cable from the monitor after use and coil it loosely for storage. |
| Quantity | 21,825 units distributed worldwide |
| Distribution | Worldwide Distribution--USA (nationwide) including Puerto Rico and countries of Australia, Brazil, Chile, Germany, Hong Kong, Mexico, The Netherlands, and New Caledonia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973486 | LIFE PAK 12 Physio-Control Corp., Jan 9, 1998 |