Recall Z-0221-2023 ยท LPC Device, Angioplasty, Laser, Coronary
Spectranetics Corporation
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.
| Date | Nov 11, 2022 (initiated Oct 14, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | 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 tes |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.