Reported Nov 23, 2022 · Ongoing
Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular…
Spectranetics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spectranetics Corporation · 9965 Federal Dr · Colorado Springs, CO · 80921-3822
Is this the product you have?
- Philips Laser System
- REFLAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads
- Lot codes and dates
- UDI-00813132027452
- Software Version0.5.0.3
- Serial Numbers
113 of 113 codes
100000100001100002100003100004100005100006100007100008100009100010100011100012100013100014100015100016100017100018100019100020100021100022100023100024100025100026100027100028100029100030100033100034100035100036100037100038100039100040100041100042100043100044100045100046100047100048100049100050100051100052100053100054100055100058100059100060100061100062100063
- Amount recalled
- 113
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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