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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Laser System

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 Class 2 Device Recall Philips Laser Systemsee related information
Date Initiated by FirmJune 01, 2022
Create DateJuly 11, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1351-2022
Recall Event ID 90364
PMA NumberP910001S115 
Product Classification Device, angioplasty, laser, coronary - Product Code LPC
ProductPhilips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Code Information Serial Numbers: 100000 to 100104 UDI/DI: (01)00813132027452
FEI Number 3007284006
Recalling Firm/
Manufacturer		 Spectranetics Corporation
9965 Federal Dr
Colorado Springs CO 80921-3822
For Additional Information ContactEmily Dentler
619-380-1318
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn June 08, 2022 Spectranetics issued a "Urgent Medical Device Correction" notification to affected consignees via USPS. The recall notification asked consignees to take the following actions: 1. Philips internal testing confirms that 1-3 reboots of the system will temporarily resolve the issue. Philips also recommends the continued use of the Philips Laser System, and to follow the Operator s Manual, as there is no expected harm to the user or patient. Philips recommends notifying all Philips Laser System users within your facility of this communication and retain a copy of this letter for reference. To acknowledge receipt of this notification, please complete, sign, and return the Customer Reply Form, included with this letter, within 30 days upon receipt of this notice to the following Email: igtdc.r@philips.com If you are a distributor or have forwarded affected device(s) to another end user, it is imperative that all end-users with affected devices receive this URGENT Medical Device Correction. Therefore, send a copy of this notification to any customer to whom you have distributed the affected product. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips IGTD Customer Service: Philips Laser System (PLS) Customer Service: Phone: 1-800-231-0978 Email: laserserviceops@philips.com Hours of Operation: Monday - Friday 9:00AM 5:00PM MST
Quantity in Commerce105 units
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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = LPC
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