LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Recall
- Recall Number
- Z-1232-2025
- Event Number
- 96095
- Firm
- Physio-Control, Inc.
- FEI Number
- 3015876
- Product Code
- MKJ
- Status
- Open, Classified
- Root Cause
- Employee error
- Initiated
- February 3, 2025
- Posted
- February 25, 2025
- Address
- 11811 Willows Rd Ne, Redmond, WA, 98052-2003
Description
LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
On 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 [email protected]. 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: [email protected] 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 [email protected].
U.S.: WV O.U.S.: N/A
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