LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions.
FDA Recall Z-1144-2017 · Posted None
Recalling FirmPhysio-Control, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2017-01-16
Date Terminated2018-09-11
Product Quantity2584 units total (1501 units in the US; 1034 units international; and 49 units owned by Physio). 50 modules total
Reason for Recall
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
Firm Action
Physio Control sent the Urgent Medical Device Correction LIFEPAK 15 Monitor/ Defibrillator and LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 (EtCO2) option letter, dated January 2017, and confirmation sheets to consignees on January 16, 2017.
Physio-Control is contacting customers with affected devices to schedule the correction of their device(s), which will include replacing the EtCO2 module.
Required Customer Actions:
1. Please forward this information to all affected sites, trainers and users that may have affected LIFEPAK 12 or LIFEPAK 15 device(s).
2. Consignees should follow the instructions on the Confirmation Sheet for each serial number listed in their possession. Promptly return the completed Confirmation Sheet to Physio-Control.
3. If consignees experience the XXX after power-up or during device operation, please contact Physio-Control to arrange for servicing of their device.
Consignees should return completed confirmation sheet:
-By fax to: 1-866-448-9567
-By email to: [email protected]
-Or by mail to: Physio-Control, Inc. P.O. Box 97006, Dept. 15N Redmond, WA, 98073-9706
Consignees with questions can call the firm at 1-800-442-1142, option 7, 6:00 A.M. to 4:00 P.M. (Pacific), Monday Friday.
Root Cause
Process control
Distribution Pattern
Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHILE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, FRENCH GUIANA, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, LITHUANIA, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SENEGAL, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TAHITI, UNITED ARAB EMIRATES, AND UNITED KINGDOM.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.