Philips Laser System LAS-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00813132027452), received between Jan 10, 2024 and Sep 16, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Oct 14, 2022Open, Classified

   Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error is cleared. May result in initiation of treatment delay and/or treatment beyond initial scope and/or unable to treat patient.

   Z-0221-2023 · Root cause: Device Design · Recall details · FDA record ↗

2. Jun 1, 2022Open, Classified

   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.

   Z-1351-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796536 ↗
• MalfunctionJun 22, 2026Energy Output Problem

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED DURING AN EMERGENT STEMI PROCEDURE, NECESSITATING THE USE OF A PHILIPS LASER SYSTEM (PLS). DURING ATTEMPTS TO CALIBRATE THE SPECTRANETICS ELCA LASER ATHERECTOMY CATHETERS, THE PLS DISPLAYED ERROR 106, WHICH RENDERED THE SYSTEM INOPERABLE. THE PROCEDURE WAS COMPLETED WITH OTHER MODALITIES, AND THERE WAS NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE PLS TERMINAL SYSTEM FAILURE, DELAY OF PROCEDURE; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25587498 ↗
• MalfunctionMay 22, 2026Connection Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PATIENT WITH A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER, NECESSITATING THE USE OF A PHILIPS LASER SYSTEM (PLS). DURING USE, THE PLS DISPLAYED AN ERROR 310, WHICH RENDERED THE SYSTEM INOPERABLE, AND THE PROCEDURE COULD NOT BE COMPLETED. THE PROCEDURE WAS POSTPONED UNTIL THE SYSTEM COULD BE REPAIRED, DELAYING TREATMENT OF THE PATIENT. THERE WAS NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE PLS SYSTEM ERROR, DELAY OF PROCEDURE; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260273 ↗
• MalfunctionMar 30, 2026Energy Output Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO TREAT A PATIENT LIKELY DUE TO INFECTION, NECESSITATING THE USE OF A PHILIPS LASER SYSTEM (PLS). A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH WAS CALIBRATED AND BEING USED WHEN THE PLS DISPLAYED ERROR 106, WHICH RENDERED THE SYSTEM INOPERABLE. THE PATIENT WAS PUT ON ANTIBIOTICS AND THE PROCEDURE WAS POSTPONED, DELAYING TREATMENT. THERE WAS NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE PLS TERMINAL SYSTEM FAILURE, DELAY OF PROCEDURE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735029 ↗
• MalfunctionMar 13, 2026Energy Output Problem

  A PROCEDURE COMMENCED TO TREAT A PATIENT, NECESSITATING THE USE OF A PHILIPS LASER SYSTEM (PLS). DURING USE, THE PLS DISPLAYED AN ERROR 106, WHICH RENDERED THE SYSTEM INOPERABLE, AND THE PROCEDURE COULD NOT BE COMPLETED. THE PROCEDURE WAS POSTPONED UNTIL THE SYSTEM COULD BE REPAIRED, DELAYING TREATMENT OF THE PATIENT. THERE WAS NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE PLS TERMINAL SYSTEM FAILURE, DELAY OF PROCEDURE; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24593776 ↗
• MalfunctionApr 18, 2025Failure to Align; Failure to Align

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA), NECESSITATING THE USE OF A PHILIPS LASER SYSTEM (PLS) TO POWER A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER. DURING PREPARATION FOR USE, THE PLS DISPLAYED AN ERROR 103 AND ERROR 106, WHICH RENDERED THE SYSTEM INOPERABLE, AND THE PROCEDURE COULD NOT BE COMPLETED. THE PROCEDURE WAS POSTPONED UNTIL THE SYSTEM COULD BE REPAIRED, DELAYING TREATMENT OF THE PATIENT. THERE WAS NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE PLS TERMINAL SYSTEM FAILURE, DELAY OF PROCEDURE; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868373 ↗
• MalfunctionMar 4, 2025Failure to Align; Failure to Align

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT THE PATIENT, NECESSITATING THE USE OF A PHILIPS LASER SYSTEM (PLS) TO POWER A SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER. DURING THE PROCEDURE, THE PLS DISPLAYED AN ERROR 106, WHICH RENDERED THE SYSTEM INOPERABLE, AND THE PROCEDURE COULD NOT BE COMPLETED. THE PROCEDURE WAS POSTPONED UNTIL THE SYSTEM COULD BE REPAIRED, DELAYING TREATMENT OF THE PATIENT. THERE WAS NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE PLS TERMINAL SYSTEM FAILURE, DELAY OF PROCEDURE; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516664 ↗
• MalfunctionOct 22, 2024Failure to Align; Failure to Align

  A PROCEDURE COMMENCED TO REMOVE AN INFERIOR VENA CAVA (IVC) FILTER FROM A JUGULAR APPROACH, DUE TO THE FILTER NO LONGER BEING NEEDED. THE PATIENT WAS ON THE TABLE, ANESTHETIZED, AND INTUBATED. DURING THE PROCEDURE, A PHILIPS LASER SYSTEM (PLS) DISPLAYED AN ERROR 106, WHICH RENDERED THE SYSTEM INOPERABLE, AND THE PROCEDURE COULD NOT BE COMPLETED. THE DECISION WAS MADE TO TERMINATE THE CASE UNTIL THE LASER COULD BE REPAIRED. THE PATIENT WAS EXTUBATED, AND THE DEVICES IN USE WERE REMOVED, WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE PLS TERMINAL SYSTEM FAILURE, DELAY OF PROCEDURE; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20511022 ↗
• MalfunctionJan 10, 2024Power Problem; Power Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERIES, DISCOVERED TO BE OCCLUDED DURING THE DIAGNOSTIC PORTION OF THE PROCEDURE. AN ATHERECTOMY WAS NECESSARY TO RELIEVE THE PATIENT''S PAIN AND SYMPTOMS. THE PATIENT WAS ON THE TABLE, AND CONSCIOUS SEDATION HAD BEEN ADMINISTERED. DURING USE, A PHILIPS LASER SYSTEM DISPLAYED A FAULT 600, WHICH RENDERED THE SYSTEM INOPERABLE, AND THE PROCEDURE COULD NOT BE COMPLETED. NO OTHER OPTIONS WERE AVAILABLE TO CROSS THE OCCLUSION, SO THE PROCEDURE WAS ABORTED, WITH PLANS TO RESCHEDULE THE PATIENT AFTER THE LASER SYSTEM WAS REPAIRED. THERE WAS NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE PLS, TERMINAL SYSTEM FAILURE, POTENTIAL FOR HARM WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489604 ↗