Z-1143-2017Class II

LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the...

Name: Z-1143-2017 LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the...
Creator: Physio-Control, Inc.
Published: 2017-01-16
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2017-01-16 / Terminated / root cause: manufacturing process

FDA source

Physio-Control, Inc. began a recall of LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments... on 2017-01-16. FDA classified it as Class II and gives the reason as "The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1143-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-16
Posted: 2017-02-07
Terminated: 2018-09-11
Recalling firm: Physio Control, Inc.
Product: LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 7 units in the US and 13 modules worldwide (5 international; and 8 owned by Physio)
Distribution: 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.
Product codes and lots: LOT NUMBERS OF AFFECTED MODULE: Lot # 1520 and 1544. SERIAL NUMBERS OF DEVICES: 32877820, 34356891, 35984435, 37223110, 37440401, 37456675, and 37913307.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1143-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1143-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-07
Z-1144-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-07

Product code MKJ

K102972Class IIILifepak 12Physio-Control, Inc. / cleared 2010-12-22

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)