FDA Medical Device Recalls (openFDA)
Physio-Control, Inc.: LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
- Recall number
- Z-1232-2025
- Recalling firm
- Physio-Control, Inc.
- Product
- LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
- Status
- Open, Classified
- Initiated
- 2025-02-03
- Posted
- 2025-02-25
- Terminated
- not on file
- Reason
- Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
- Root cause
- Employee error
- Action
- 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 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
- 1
- Distribution
- U.S.: WV O.U.S.: N/A
- Lot, serial or model codes
- Model/Catalog Number: 99507-000001 UDI-DI code: 00883873813751 Serial Number: 38289467
- 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
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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