LUCAS Chest Compression Systems Recalled for Inadequate Service Documentation
Jolife AB is recalling 153 LUCAS chest compression systems (Models 2, 3, and 3.1) due to incomplete service documentation. Service work performed on affected systems was not properly documented in service records.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a documentation deficiency rather than a direct patient safety hazard. No illnesses, injuries, or device malfunction are reported; the issue is incomplete service documentation, which is a compliance and record-keeping problem.
Plain-English summary
Jolife AB is recalling 153 LUCAS chest compression systems, including Model Numbers 99576 (LUCAS 2, LUCAS 3, and LUCAS 3.1), due to a documentation deficiency in their service records. A subset of these devices received service work, but the documents justifying the passing results from that service were not properly included in the systems' service records.
LUCAS chest compression systems are used to perform external cardiac compressions on adult patients experiencing acute circulatory arrest (defined as absence of spontaneous breathing and pulse, and loss of consciousness). The recalled systems were distributed nationwide across the following states: Alabama, Arizona, California, Florida, Hawaii, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, Nevada, Ohio, South Carolina, Texas, Utah, Virginia, Washington, and Wyoming.
Users in possession of any recalled LUCAS system should contact Jolife AB for guidance regarding their specific device, referencing the model number, catalog number, UDI-DI code, and serial number of the affected system. The specific serial numbers of recalled units are provided by Jolife AB for identification purposes.
The recalled product
- Product
- 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: 0088
- Manufacturer
- Jolife AB
- Hazard
- incomplete-documentation
- service-record-deficiency
Distribution
Distributed nationwide across the United States.