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Recall Observatory FDA recall evidence

Device product

LUCAS 2, 3 and 3.1 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.

Z-1998-2025

May 21, 2025

Class II

Product summary

Firm
Jolife AB
Event
Event 96729
Status
Ongoing
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-1998-2025

Official wording

Reason: Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.

Code information: Lucus 2 Catalog Number: 99576-000025 UDI-DI code: 00883873904565 Serial Number: 30090111 Lucas 3 Catalog Number: 21331-000081 UDI-DI code: 00883873861875 Serial Numbers: 35172335 35160570 Lucas 3.1 Catalog Number: 94576-000005 UDI-DI code: 00883873834329 Serial Numbers: 3518A164 3518D104 (Scrapped)

Distribution pattern: U.S. Nationwide distribution in the states of IN, MI, OH and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.