Spectranetics Corporation Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Brand
Spectranetics Corporation
Lot Codes / Batch Numbers
Serial Numbers: 100000 to 100104 UDI/DI: (01)00813132027452
Products Sold
Serial Numbers: 100000 to 100104 UDI/DI: (01)00813132027452
Spectranetics Corporation is recalling Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 1 due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KS, LA, ME, MD, MA, MI, MN, MO, NJ, NY, NC, OK, PA, TN, TX, VA
Page updated: Jan 10, 2026