Z-1257-2017Class I

The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical...

Name: Z-1257-2017 The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical...
Creator: Physio-Control, Inc.
Published: 2017-01-13
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2017-01-13 / Terminated / root cause: design

FDA source

Physio-Control, Inc. began a recall of The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the... on 2017-01-13. FDA classified it as Class I and gives the reason as "The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage". 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-1257-2017
Classification: Class I
Status: Terminated
Initiated: 2017-01-13
Posted: 2017-03-03
Terminated: 2019-08-22
Recalling firm: Physio Control, Inc.
Product: The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.
Root cause tag: design
FDA root cause: Device Design
Action: Physio Control sent an Urgent Medical Device Correction letter dated January 2017 to all affected customers. The firm issued the press release on January 13, 2017. The link to press release is http://www.fda.gov/Safety/Recalls/ucm537114.htm. The firm also started mailing letter, confirmation sheet, check list to consignees on January 13, 2017. On August 28, 2017, the US begun contacting customers that have not yet responded to the previous mailings. Information about this notice is available at: www.physio-control.com/lifepak1000-274. Customers were instructed to immediately remove and reinstall the battery from their LIFEPAK 1000 defibrillator. The removal and reinstallation of the battery will clean the contacts of oxidation and will restore power to the device. It is critically important that customers implement a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices. Removing and reinstalling the battery on a weekly basis will help ensure their device is ready for use. Customers were also advised to always carry a spare, fully charged battery. The weekly schedule of battery removal must be performed until their device correction has been completed. Customers were asked to forward this information to all of their sites, trainers and users who have LIFEPAK 1000 devices. The Customer Letter was updated on the web page to clarify the statement "It is also important to always carry a spare, fully charged battery" was provided as a reminder to customers and is consistent with what is stated in the LIFEPAK 1000 Defibrillator Operating Instructions. Customers were asked to complete and return the Confirmation Sheet to Physio-Control. Customers with questions regarding this notification, please contact Physio-Control by calling 1-866-231-1220, 6:00 a.m. to 4:00 p.m. (Pacific) Monday Friday, or by email to [email protected] or fax to 1-866-448-9567. **************************************
Quantity in commerce: total 133,330 units (50,046 units in the US)
Distribution: Worldwide Distribution - US (nationwide) and in the following countries: Bahrain, Belize, Cambodia, Chile, China, C¿te d'Ivoire, Ecuador, Germany, Honduras, Hong Kong, India, Indonesia, Jamaica, Myanmar, Netherlands, Niger, Philippines, Saudi Arabia, Senegal, Singapore, Sri Lanka, Thailand, Tunisia, Ukraine, and Zambia.
Product codes and lots: Affected Product Part Numbers: 320371500XX. There are 133,330 affected serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1257-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1257-2017	Class I	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-03

Product code MKJ

K122600Class IIILifepak 1000 DefibrillatorPhysio-Control, Inc. / cleared 2012-10-11

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)