Philips LAS-100 Laser System may not operate due to detected hardware failure
Spectranetics' Philips LAS-100 Laser System (105 units) may fail to start if the device detects an inoperable hardware component during power-up, requiring manual error code clearing before operation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported injuries or illnesses. The hazard is operational failure (device not starting due to hardware detection), not a direct risk of patient harm. No hospitalization reports are documented. This is a precautionary recall for a functional defect.
Plain-English summary
Spectranetics Corporation has recalled 105 units of the Philips LAS-100 Laser System. The system may detect an inoperable hardware component during power-up, resulting in an error code that prevents operation until the error is manually cleared.
The affected units are identified by serial numbers 100000 through 100104. They were distributed to 27 U.S. states and internationally to Saudi Arabia, Denmark, France, Greece, India, Italy, Netherlands, Serbia, Spain, Sweden, and the United Kingdom.
Facilities and operators should check their equipment against the serial number range to determine if they have an affected unit.
The recalled product
- Product
- Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
- Manufacturer
- Spectranetics Corporation
- Category
- Medical Device — Laser System
- Hazard
- hardware-failure
- operational-failure
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 (1)
- Serial Numbers: 100000 to 100104 UDI/DI: (01)00813132027452
Distribution
Distributed in 27 states:
- 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
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