FDA Device recall Z-0221-2023
Philips Laser System, REF: LAS-100
- FDA Device
- Class II
- ongoing
- Published 2022-11-23
On 2022-11-23 the FDA classified a Class II recall of Philips Laser System, REF: LAS-100 by Spectranetics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0221-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-14 |
| Published | 2022-11-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Spectranetics |
| Distribution | AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OK, OR, PA, TN, TX, VA |
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.
Identifiers
| code_info | UDI-00813132027452, Software Version: 0.5.0.3, Serial Numbers: 100000, 100001, 100002, 100003, 100004, 100005, 100006,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Spectranetics
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FDA Device · Class I · 2025-02-26 · Spectranetics - Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 98993…
FDA Device · Class II · 2024-12-25 · Spectranetics - Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 42…
FDA Device · Class II · 2023-12-20 · Spectranetics - Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
FDA Device · Class II · 2022-07-20 · Spectranetics - Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Out…
FDA Device · Class II · 2020-06-03 · Spectranetics
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0221-2023%22
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