CLASS II ONGOING Device recall · Reported 23 Nov 2022 · FDA Enforcement Report
Philips Laser System recalled by Spectranetics
Spectranetics is recalling Philips Laser System, distributed in 30 states. The recall was initiated on 14 Oct 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0221-2023
- FDA event ID
- 90971
- Recalling firm
- Spectranetics, Colorado Springs, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Oct 2022
- FDA classified
- 11 Nov 2022
- Reported
- 23 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Pacemakers & Defibrillators
Timeline
| 14 Oct 2022 | Recall initiated by company | |
| 11 Nov 2022 | Classified by FDA | +28 days |
| 23 Nov 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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
ArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasLouisianaMassachusettsMarylandMaineMichiganMinnesota
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Spectranetics
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Intact Vascular Tack Endovascular System recalled by Spectranetics | Spectranetics | Potency & Assay | Nationwide |
| Device | CLASS II | Turbo-Elite Laser Atherectomy Catheter 2.0 RX recalled by Spectranetics | Spectranetics | Packaging Defects | Nationwide |
| Device | CLASS II | Philips Laser System recalled by Spectranetics | Spectranetics | Other | 23 states |
| Device | CLASS II | Bridge Occlusion Balloon recalled by Spectranetics | Spectranetics | Device Malfunction | Nationwide |
| Device | CLASS II | AngioSculpt PTCA Scoring Balloon Catheter recalled by Spectranetics | Spectranetics | Other | IA, MI, NJ |
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|---|---|---|---|---|---|
| Device | CLASS II | DermaV Laser System recalled by Lutronic | Lutronic | Other | Nationwide |
| Device | CLASS II | Convenience kits containing select SKUs of Polycarbonate recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled | Medline Industries | Device Malfunction | Nationwide |