LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
Recall
- Recall Number
- Z-2161-2026
- Event Number
- 98417
- Firm
- Jolife AB Scheelevagen 17 Ideon Science Park Lund Sweden
- FEI Number
- 3005445717
- Product Code
- DRM
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- April 13, 2026
- Posted
- May 11, 2026
Description
LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).
On 04/13/2026, the firm sent via US Postal an "Urgent: Medical device correction" letter informing customers that through complaint reviews, Stryker discovered a subset of work orders performed between July 2023 through November 2025 with Performance Inspection Procedures (PIP) recorded as PASS without the corresponding objective evidence properly documented in the work orders. Customers are instructed to: 1. Immediately check internal inventory to locate the affected product as listed. 2. Return the business reply form by email to [email protected] to confirm receipt of this notification. 3. Upon receipt of the completed business reply form, Stryker will contact customers to arrange for corrective action on the device if service has not been performed. 4. There are no additional actions that users can and should take. 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. Maintain awareness of this communication internally until all required actions have been completed within their facility. Ensure this letter is kept with the affected device until the correction has been completed. 6. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details, so Stryker can inform the recipients appropriately. Any questions or concerns, contact Customer Service +1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday Friday or by email at [email protected].
U.S. Nationwide distribution in the states of AL, AZ, CA, FL, HI, IA, KS, KY, LA, MA, MD, MN, NC, NV, OH, SC, TX, UT, VA, WA, and WY.
153 systems