| 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-2497-2025 |
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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 15 Part / Catalog Numbers / UDI-DI code:
V15-7-000022 / 99577-001957 / 883873871690
V15-2-000051 / 99577-000046 / 883873988022
V15-2-000099 / 99577-000093 / 883873979020
V15-2-001603 / 99577-001256 / 883873911631
LIFEPAK 15: The LP15 is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older. |
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| Code Information |
Part / Catalog Numbers / UDI-DI code / Serial Number:
V15-7-000022 / 99577-001957 / 883873871690 / 49085553
V15-2-000051 / 99577-000046 / 883873988022 / 38154524
V15-2-000099 / 99577-000093 / 883873979020 / 39059475
V15-2-001603 / 99577-001256 / 883873911631 / 40973093
|
| 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 | 4 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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