LUCAS 2 Chest Compression System. The device's Instruction for Use is labeled in part: "LUCAS 2 Chest Compression System
FDA device recall Z-1664-2011 · posted 2011-03-16 · Terminated
Recall details
- Recalling firm
- Jolife AB
- Reason for recall
- LUCAS 2 Chest Compression System may have malfunctions resulting from the failure of a hood probe on the device that connects to the battery. The device may stop in fail safe mode and the LEDs will start flickering or the device will switch off.
- Action taken
- Medical Device Correction letter, dated February 2011, was sent to customers and states that Jolife AB with the servicing support assistant of Physio-Control is conducting a voluntary upgrade of the LUCAS 2 Chest Compression System with the Serial number range of 30090016 through 30101932. Consignees were advised to keep LUCAS 2 in service and continue to use it in accordance with the Instruction for Use, Section 3.8-Safety Precautions. WARNING-MALFUNCTION. If there are interruptions, or the compressions are not sufficient or something unusual occurs during operation: Push ON/OFF for 1 second to stop LUCAS and remove the device. Start Manual chest compression. Physio-Control service representative will contact the consignees to schedule a service call to replace the affected battery connector board in the hood of the device. The new connector board will include a new probe design in which current cannot affect the spring. Consignees can contact Physio-Control Technical Support at 1-800-442-1142, #5 between 6 am-4 pm (Pacific Time), Monday-Friday or visit the website www.physio-control-notices.com/LUCAS2. If customers no longer have the affected device or the device location has changed they should contact Physio-Control Technical Support.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRM
- Quantity affected
- 1843 units
- Distribution
- Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait
- Date initiated
- 2011-02-08
- Date posted
- 2011-03-16
- Date terminated
- 2012-04-24
- Location
- Lund, Sweden
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUCAS 2 (K090422) | Jolife AB | 2009-06-17 |