Z-0230-2025Class II

LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o...

Name: Z-0230-2025 LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o...
Creator: Physio-Control, Inc.
Published: 2024-08-30
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2024-08-30 / Open, Classified / root cause: supplier

FDA source

Physio-Control, Inc. began a recall of LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o... on 2024-08-30. FDA classified it as Class II and gives the reason as "Due to an out of tolerance tool being used on monitor/defibrillator systems". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0230-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-30
Posted: 2024-10-25
Recalling firm: Physio Control, Inc.
Product: LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Due to an out of tolerance tool being used on monitor/defibrillator systems.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: On 09/30/2024, the firm mailed an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customers informing them that Stryker discovered that an out of tolerance service tool was used on affected LP15 devices in which there is a potential for Noninvasive Blood Pressure (NIBP), System or Auxiliary Power Connectors to be loose. There is a possibility that water or dust may accumulate in the ingress and can lead to permanent or intermittent failures. Customers are instructed to: 1. Immediately check internal inventory to locate the product listed on the attached business reply form. 2. To confirm receipt of this Medical Device Correction Notice and understanding of the provided information, email the enclosed Business Reply Form (BRF) by October 31st, 2024 date, to [email protected]. 3. Upon receipt of the completed business reply form, Stryker will contact customers to arrange for corrective action on the device. 4. There are no additional actions that users can and should take. Please continue to follow the Operating Instructions and perform the daily checks and user tests. These tests can be found in the chapter Maintaining the Equipment subsection General Maintenance and Testing . 5. In the interim, Stryker recommends that you continue to use your LP15 device. 6. Maintain awareness of this communication internally until all required actions have been completed within your facility. Please ensure this letter is kept with the affected device until the correction has been completed. 7. Inform Stryker if any of the subject devices have been distributed to other organizations by contacting Stryker at: a. Device Tracking: [email protected] b. Website: https://www.strykeremergencycare.com/service-support-overview/device-registration/ If you have any questions or concerns, please contact Customer Service +1 800 442 1142 or by email [email protected].
Quantity in commerce: 105 systems
Distribution: U.S.: CT, GA, MA, NY, OH, WA, and WV. O.U.S.: N/A
Product codes and lots: LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 UDI-DI codes: o 00883873808214 o 00883873988022 o 00883873979426 o 00883873979358 o 00883873911693 o 00883873979198 o 00883873911648 o 00883873884386 o 00883873871713 o 00883873871706 o 00883873871690 o 00883873871683 o 00883873911631 o 00883873871645 Serial Numbers: o 45435833 o 46470647 o 46686048 o 46686573 o 46686708 o 46687360 o 46906073 o 49037777 o 49704552 o 38166647 o 38282988 o 38290136 o 38291331 o 38802782 o 39541663 o 39541666 o 39752193 o 40259639 o 41446867 o 41447020 o 41453331 o 42325059 o 43574409 o 43984215 o 45040678 o 45308104 o 45455023 o 46017745 o 46572054 o 46576300 o 48349664 o 48605645 o 48605663 o 49001744 o 49025185 o 49070762 o 49087040 o 49087053 o 49224619 o 49374174 o 49422314 o 49619921 o 38200440 o 38805564 o 38805583 o 39382735 o 41446693 o 41446882 o 41446975 o 41446977 o 41447027 o 41453239 o 41893891 o 42324176 o 42610924 o 43181935 o 43182268 o 43182389 o 43462227 o 43465372 o 43487806 o 43610792 o 43791346 o 43841374 o 43860850 o 43862247 o 43869747 o 44169862 o 44356379 o 44360003 o 44601246 o 45590467 o 45907317 o 46364496 o 46691551 o 47447195 o 47515791 o 47539203 o 47539310 o 47785570 o 47794250 o 48524850 o 48583111 o 48585709 o 48600317 o 48605407 o 48605467 o 48704914 o 48749443 o 49022830 o 49031342 o 49036187 o 49056308 o 49057928 o 49123367 o 49126651 o 49127012 o 49132399 o 49132740 o 49134638 o 49511402 o 49513814

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0230-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0230-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-25

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)