--- title: "Philips Laser System, REF: LAS-100. Used in minimally invasive interventional... — FDA record Z-0221-2023 | Is It on Recall" description: "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 proc" url: https://isitonrecall.com/recall/fda-device-z-0221-2023-philips-laser-system-ref-las-100-used-in-minimally-invasive-interventional-procedures-within-the-car/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular sy... — FDA record Z-0221-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Oct 14, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **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. - **Reason**: 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. - **Classification**: Class II - **Recalling firm**: Spectranetics Corporation - **Quantity**: 113 - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0221-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0221-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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, 100018, 100019, 100020, 100021, 100022, 100023, 100024, 100025, 100026, 100027, 100028, 100029, 100030, 100033, 100034, 100035, 100036, 100037, 100038, 100039, 100040, 100041, 100042, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100053, 100054, 100055, 100058, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100074, 100075, 100076, 100077, 100078, 100079, 100080, 100081, 100082, 100083, 100084, 100085, 100086, 100087, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 100106, 100107, 100108, 100112, 100113, 100114, 100115, 100116, 100117, 100118, 100120 | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US: LA, MO, TN, CA, NC, PA, HI, AZ, CO, OK, FL, TX, MN, MI, VA, CT, NY, MD, IL, NJ, MA, KS, ME, AR, IA, IN, GA, ID, OR. OUS: DE, GB, ES, SE, IT, RS, GR, IN, FR, IL, DK, SA States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New York](https://isitonrecall.com/state/new-york/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Virginia](https://isitonrecall.com/state/virginia/) ## Dates in the source - **Report date**: Nov 23, 2022 - **Recall initiation date**: Oct 14, 2022 - **Center classification date**: Nov 11, 2022 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0221-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Spectranetics Corporation records](https://isitonrecall.com/brand/spectranetics-corporation/)