Philips Laser System, REF LAS-100, Intermittent Operation… recallZ-1351-2022 · Spectranetics Corporation · initiated Jun 1, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Spectranetics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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: [email protected] 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: [email protected] Hours of Operation: Monday - Friday 9:00AM 5:00PM MST
Recall details
- Recall number
- Z-1351-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 1, 2022
- Recalling firm
- Spectranetics Corporation
- Quantity
- 105 units
- Product code
- LPC
- FDA submissions
- P910001S115
- 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
Product description
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Code information (models, lots, serial numbers)
Serial Numbers: 100000 to 100104 UDI/DI: (01)00813132027452
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Philips Laser System LAS-100Spectranetics Corporation · Device, Angioplasty, Laser, Coronary2 recalls9 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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