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Philips Laser System, REF: LAS-100. Used in minimally… recallZ-0221-2023 · Spectranetics Corporation · initiated Oct 14, 2022

Class II Open, Classified All recalls posted in November 2022

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Spectranetics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Device Design

What the company is doing

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 [email protected]

Recall details

Recall number
Z-0221-2023
Recall class
Class II
Status
Open, Classified
Initiated by the company
Oct 14, 2022
Posted by the FDA
Nov 11, 2022
Recalling firm
Spectranetics Corporation
Quantity
113
Product code
LPC
FDA submissions
P910001S112
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

Product description

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 (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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