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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Laser System LAS100

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  Class 2 Device Recall Philips Laser System LAS100 see related information
Date Initiated by Firm October 14, 2022
Date Posted November 11, 2022
Recall Status1 Open3, Classified
Recall Number Z-0221-2023
Recall Event ID 90971
PMA Number P910001S112 
Product Classification Device, angioplasty, laser, coronary - Product Code LPC
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.
Code Information 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
Recalling Firm/
Manufacturer		 Spectranetics Corporation
9965 Federal Dr
Colorado Springs CO 80921-3822
For Additional Information Contact
719-633-8333
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action On 10/14/22, correction notices were mailed to customers who were asked to take the following actions: Firm recommends continued use of affected devices and to follow the operator's manual. As a temporary mitigation, until software becomes available tentatively in Q2 2023, the user can perform steps when visually alerted on the system display as follows: Error 106 Firm's internal testing confirms that the following steps may temporarily resolve the issue, if encountered: 1. System restart 2. Recalibration of the catheter in use or calibration of a new catheter Error 108 Firm's internal testing confirms that the following steps will resolve the issue, if encountered: 1. System restart 2. Recalibration of the catheter in use or calibration of a new catheter 3. Once the system is in the Ready State, pause 2 seconds before pressing the footswitch Firm recommends all affected device users within their facility are notified of correction and a copy of the correction notice should be retained. Complete and return the Customer Reply Form. Tentatively in Q2 2023, firm will contact all affected customers and arrange for a Field Service Engineer to update the system software during preventive maintenance or service visits. Distributors are asked to send the notice and response form to customers to whom affected devices were distributed and to follow-up with these customers to obtain signed response forms. Customers with additional questions are encouraged to call 1-800-231-0978 (option 1), Monday - Friday 9:00AM - 5:00PM MST, or email laserserviceops@phiIips.com
Quantity in Commerce 113
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = LPC and Original Applicant = SPECTRANETICS CORP.
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