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Spectranetics Corporation Recall 90364

Description: Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM

Spectranetics Corporation Recall 90364 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1351-2022
Event ID90364
Event DescriptionPhilips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Product TypeDevices
DistributionUS: 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
Quantity105 units
Recall ReasonThe 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.
Device Classification20220720
Device Code InfoSerial Numbers: 100000 to 100104 UDI/DI: (01)00813132027452
Center Classification Date20220711
Recall Initiation Date20220601
Recalling FirmSpectranetics Corporation
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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