Physio-Control, Inc.: LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.

Recall number

Z-2498-2025

Recalling firm

Physio-Control, Inc.

Product

LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.

Status

Open, Classified

Initiated

2025-07-22

Posted

2025-09-02

Terminated

not on file

Reason

Due to required inspections not being performed on products/units that have gone through servicing.

Root cause

Under Investigation by firm

Action

On 07/22/2025, the firm sent via certified mail an "URGENT: Medical device recall" Letter to customers informing them that, Stryker discovered a subset of work orders performed between August 10th 2022 and October 30th 2023 with Performance Inspection Procedures (PIP) recorded as PASS without the corresponding objective evidence properly documented in the work order to ensure the devices are performing as intended. Customers are instructed to: 1. Immediately check their inventory to locate the affected product as listed in the letter. 2. On the business reply form, customer need to indicate if their devices have been serviced since October 30th 2023 (after that time, if affected device have undergone Preventative Maintenance through Stryker, Stryker has verified that the PIPs were completed and passed in accordance with the required standards. For these devices No additional action is required. 3. Return business reply form. Upon receipt, Stryker will contact customers to arrange for corrective action on the device if service has not been performed. 4. There are no additional actions that users can and should take. Continue to follow the Operating Instructions and perform the daily checks and user tests. Tests can be found in the chapter "Maintaining the Equipment' subsection "General Maintenance and Testing" For Questions or concerns, contact Customer Service at +1 800 787-9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time, Monday thru Friday or email medtechsup@stryker.com

Quantity

3 units

Distribution

U.S. Nationwide distribution in the states of CO and MT.

Lot, serial or model codes

Part / Catalog Numbers / UDI-DI code / Serial Number: 320371500023 / 99425-000025 / 885074698953 / 35942190 320371500229 / 99425-000025 / 885074698953 / 41012118 331706400001 / 99425-000025 / 885074698953 / 48988273

510(k) numbers

not on file

PMA numbers

["P160026"]

Product code

MKJ

Firm FEI

3015876

Firm city

Redmond

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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