Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60H
Summary
The FDA issued a Class II for Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent by Spectranetics Corporation. Reason: 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.
Details
Source
Device Recall
External ID
Z-1351-2022
Action Date
2022-07-20
Status
Ongoing
Category
device
Product Description
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Lot/Code Info: Serial Numbers: 100000 to 100104 UDI/DI: (01)00813132027452
Quantity Affected: 105 units
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
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-01
Company
Colorado Springs, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Spectranetics Corporation has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Spectranetics Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Spectranetics Corporation have FDA actions?
Spectranetics Corporation has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1351-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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