| Date Initiated by Firm | July 22, 2025 |
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| Date Posted | September 02, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2498-2025 |
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| Recall Event ID |
96949 |
| PMA Number | P160026 |
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| Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
|
| 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. |
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| Code Information |
Part / Catalog Numbers / UDI-DI code / Serial Number:
320371500023 / 99425-000025 / 885074698953 / 35942190
320371500229 / 99425-000025 / 885074698953 / 41012118
331706400001 / 99425-000025 / 885074698953 / 48988273
|
| FEI Number |
3015876
|
Recalling Firm/
Manufacturer |
Physio-Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
|
| For Additional Information Contact | Joyce Staggs
425-867-4597 |
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Manufacturer Reason
for Recall | Due to required inspections not being performed on products/units that have gone through servicing. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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 |
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| Quantity in Commerce | 3 units |
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| Distribution | U.S. Nationwide distribution in the states of CO and MT. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| PMA Database | PMAs with Product Code = MKJ
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