Z-1351-2022 Class II Ongoing
FDA device recall Z-1351-2022 was initiated by Spectranetics Corporation on June 1, 2022 and is designated Class II. Reason for recall: The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared. The recall status is ongoing. Affected quantity: 105 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 20, 2022
- Initiation Date
- June 1, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105 units
Product Description
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Reason for Recall
The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared.
Distribution Pattern
US: AR AZ CA CO CT FL GA HI IA IL IN KS LA MA MD ME MI MN MO NC NJ NY OK PA TN TX VA OUS: Saudi Arabia, Denmark, France, Greece, India, Italy, Netherlands, Serbia, Spain, Sweden, United Kingdom
Code Information
Serial Numbers: 100000 to 100104 UDI/DI: (01)00813132027452