LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99

FDA device recall Z-0230-2025 · posted 2024-10-25 · Open, Classified

Recall details

Recalling firm

Physio-Control, Inc.

Reason for recall

Due to an out of tolerance tool being used on monitor/defibrillator systems.

Action taken

On 09/30/2024, the firm mailed an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customers informing them that Stryker discovered that an out of tolerance service tool was used on affected LP15 devices in which there is a potential for Noninvasive Blood Pressure (NIBP), System or Auxiliary Power Connectors to be loose. There is a possibility that water or dust may accumulate in the ingress and can lead to permanent or intermittent failures. Customers are instructed to: 1. Immediately check internal inventory to locate the product listed on the attached business reply form. 2. To confirm receipt of this Medical Device Correction Notice and understanding of the provided information, email the enclosed Business Reply Form (BRF) by October 31st, 2024 date, to RSRecall@Stryker.com. 3. Upon receipt of the completed business reply form, Stryker will contact customers to arrange for corrective action on the device. 4. There are no additional actions that users can and should take. Please continue to follow the Operating Instructions and perform the daily checks and user tests. These tests can be found in the chapter Maintaining the Equipment subsection General Maintenance and Testing . 5. In the interim, Stryker recommends that you continue to use your LP15 device. 6. 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 the correction has been completed. 7. 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/ If you have any questions or concerns, please contact Customer Service +1 800 442 1142 or by email RSRecall@Stryker.com.

Root cause

Vendor change control

Status

Open, Classified

Product code

MKJ

Quantity affected

105 systems

Distribution

U.S.: CT, GA, MA, NY, OH, WA, and WV. O.U.S.: N/A

Date initiated

2024-08-30

Date posted

2024-10-25

Location

Redmond, WA