Recall Z-1998-2025— Jolife AB
Class II · Ongoing
Class II FDA medical device recall by Jolife AB, initiated 2025-05-21. It names 2 FDA 510(k) clearances: K161768, K090422. 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.. Reason: Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use..
- Recalling firm
- Jolife AB
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-21
- Firm location
- Lund, Sweden
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.