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LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors recallZ-1232-2025 · Physio-Control, Inc. · initiated Feb 3, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Physio-Control, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Incorrect keypad was incorrectly installed onto a defibrillator/monitor.

FDA root cause category: Employee error

What the company is doing

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].

Recall details

Recall number
Z-1232-2025
Status
Open, Classified
Initiated by the company
Feb 3, 2025
Posted by the FDA
Feb 25, 2025
Recalling firm
Physio-Control, Inc.
Quantity
1
Product code
MKJ
FDA submissions
P160026
Distribution
U.S.: WV O.U.S.: N/A

Product description

LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.

Code information (models, lots, serial numbers)

Model/Catalog Number: 99507-000001 UDI-DI code: 00883873813751 Serial Number: 38289467

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

26 devices cleared under P160026 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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