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U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK 20e

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 Class 2 Device Recall LIFEPAK 20esee related information
Date Initiated by FirmFebruary 03, 2025
Date PostedFebruary 25, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1232-2025
Recall Event ID 96095
PMA NumberP160026 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductLIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Code Information Model/Catalog Number: 99507-000001 UDI-DI code: 00883873813751 Serial Number: 38289467
FEI Number 3015876
Recalling Firm/
Manufacturer		 Physio-Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information ContactJoyce Staggs
425-867-4597
Manufacturer Reason
for Recall		Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
FDA Determined
Cause 2		Employee error
ActionOn 02/03/2025, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via mail to a customer inform them that Stryker discovered that a keypad was incorrectly installed onto a LIFEPAK 20e defibrillator/monitor. There is a possibility that the incorrectly installed keypad may cause difficulty or the inability to actuate the keypad or buttons resulting in the inability to utilize the device. Additionally, there is a chance of water ingress or contamination resulting in damage to the internal machinery of the device. Customers are instructed to: 1. Immediately check your internal inventory to locate the product listed on the attached business reply form. 2. Please remove and quarantine the affected product from use. 3. To confirm receipt of this Medical Device Correction Notice and understanding of the provided information, please email the enclosed Business Reply Form (BRF) by January 31st, 2025 date, to RSRecall@Stryker.com. 4. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the return and replacement of your product(s). 5. 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 replacement. 6. Inform Stryker if any of the subject devices have been distributed to other organizations by contacting Stryker at: a. Device Tracking: rsdevicetracking@stryker.com b. Website: https://www.strykeremergencycare.com/service-support-overview/device-registration/ For question or concerns - contact Customer Service +1 800 442 1142 or by email RSRecall@Stryker.com.
Quantity in Commerce1
DistributionU.S.: WV O.U.S.: N/A
Total Product Life CycleTPLC Device Report
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.
PMA DatabasePMAs with Product Code = MKJ
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