Philips Laser System may enter non-recoverable error state
The Philips Laser System (REF: LAS-100) may experience system failures (Error 106 or 108) that prevent further treatment during cardiac procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a critical cardiac device where system failures can delay, extend, or prevent necessary treatment. No injuries or illnesses are reported in the source, but the device poses a clear risk of harm during critical cardiovascular procedures, meeting the criterion for a High-severity recall.
Plain-English summary
The Philips Laser System, REF: LAS-100, used for minimally invasive cardiovascular procedures and pacemaker/defibrillator lead removal, is subject to this recall. A total of 113 units with specific serial numbers are affected.
The system may detect Error 106 or Error 108 and enter a non-recoverable safe state. Once in this state, users cannot proceed with treatment until the error is manually cleared. This system failure can cause delays in treatment, extend the procedure beyond its intended scope, or prevent patient treatment entirely.
If you use this device, monitor for the specified error codes. Contact Spectranetics Corporation immediately if your system experiences Error 106 or Error 108. Consult the manufacturer's guidance before attempting any manual intervention.
The recalled product
- Product
- Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.
- Manufacturer
- Spectranetics Corporation
- Affected units
- 113
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-00813132027452
- Software Version: 0.5.0.3
- Serial Numbers: 100000
- 100001
- 100002
- 100003
- 100004
- 100005
- 100006
- 100007
- 100008
- 100009
- 100010
- 100011
- 100012
- 100013
- 100014
- 100015
- 100016
- 100017
Distribution
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