Drug recall
Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the…
FDA recall event 90971 · Class II · Spectranetics Corporation
Key facts
| Event ID | 90971 |
|---|---|
| Recall numbers | Z-0221-2023 |
| Recalling firm | Spectranetics Corporation |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Oct 14, 2022 |
| Report date | Nov 23, 2022 |
| City | Colorado Springs |
| State | CO |
| Country | United States |
| FEI number | 3007284006 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: