FDA-Device2026-05-20Class IIPROCESSING DEFECT
Jolife LUCAS chest compression systems recalled for inadequate service documentation
What this means
A subset of Jolife LUCAS 2, LUCAS 3, and LUCAS 3.1 chest compression devices did not have complete service documentation on file. The service records lack paperwork that would verify these devices passed their required checks. This affects 153 devices across 20 U.S. states.
- Check if your device's serial number matches the FDA recall list.
- Contact Jolife or your equipment supplier to verify your device's service documentation.
- Follow any instructions from the manufacturer or FDA regarding your specific device.
The agency's original wording
Hazard
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).
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
153 systems
Manufactured in
Scheelevagen 17, Ideon Science Park, Lund, Sweden
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2161-2026Want us to check the next one for you?
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