12-lead ECG Cable Assembly contains the following cable and attachments: Main Cable with Limb Leads: The main cable incl
FDA device recall Z-2625-2011 · posted 2011-06-22 · Terminated
Recall details
- Recalling firm
- Physio Control, Inc.
- Reason for recall
- 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.
- Action taken
- 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. Please refer to the Storage Instructions for 12-lead ECG Cable. -Inspect cables daily for bulges which may indicate damaged internal wires. If bulges are visible, replace the ECG cable. -Perform periodic 6 month function testing: Refer to Maintenance and Testing Schedule in the LIFEPAK 12 or LIFEPAK 15 Operating Instructions- Maintaining the Equipment chapters for instructions on how to perform a patient ECG cable function check to confirm proper operation of the cable. Customers can visit Physio-Control's website at www.physio-control-notices.com/12LeadECG for additional information or to download copies of current LIFEPAK 12 defibrillator/monitor or LIFEPAK 15 monitor/defibrillator Operating Instructions and Operator's checklists. Customers can also call Physio-Control's Technical Support Team at 1-800-442-1142, option 5, from 6:00 A.M. to 4:00 P.M. (Pacific), Monday-Friday.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 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.
- Date initiated
- 2011-05-11
- Date posted
- 2011-06-22
- Date terminated
- 2011-08-12
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFE PAK 12 (K973486) | Physio-Control Corp. | 1998-01-09 |