Z-2625-2011

12-lead ECG Cable Assembly contains the following cable and attachments: Main Cable with Limb Leads: The main...

Name: Z-2625-2011 12-lead ECG Cable Assembly contains the following cable and attachments: Main Cable with Limb Leads: The main...
Creator: Physio Control, Inc.
Published: 2011-05-11
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2011-05-11 / Terminated / root cause: design

FDA source

Physio Control, Inc. began a recall of 12-lead ECG Cable Assembly contains the following cable and attachments: Main Cable with Limb Leads: The main cable includes the proximal connector which... on 2011-05-11. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2625-2011
Status: Terminated
Initiated: 2011-05-11
Posted: 2011-06-22
Terminated: 2011-08-12
Recalling firm: Physio Control, Inc.
Product: 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 includes the precordial connector which attaches to the main cable with six precordial leads (also terminated with ECG electrode snaps). This attachment is used when a 12-lead ECG is needed. The main cable includes a cover over the connector for the precordial lead attachment to protect it from contaminants if the precordial lead attachment is not connected. This 12-lead ECG Cable Assembly is designed for use in the Pre-hospital and hospital environment. The 12-lead ECG cables are currently available for the LIFEPAK 12 Defibrillator/Monitor and LIFEPAK 15 Monitor/Defibrillator. The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute ST elevation myocardial infarction (STEMI). Documentation of transient or intermittent arrhythmias and other electrophysiologic events that occur in the prehospital setting can assist in diagnosis and treatment decisions in the Emergency Department.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: design
FDA 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. 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.
Quantity in commerce: 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.
Product codes and lots: 12-lead ECG Cable with Limb Lead Attachment Part Numbers: 3302822-000-AHA; 3302822-002-AHA; 3302822-001-IEC; 3302822-003-IEC. Precordial Lead Attachment Part Numbers: 3302823-000-AHA and 3302823-001-IEC. No Serial numbers for 12-Lead ECG Cable.

Product code MKJ

K973486Class IIILife Pak 12Physio-Control Corp. / cleared 1998-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)