Z-1836-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- March 6, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Reason for Recall
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
Distribution Pattern
US: in the state of California
Code Information
Serial Numbers: 902-754R2692N002 and 902-754R2692N001