Spectranetics Corporation Recall 90364
Description: Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Spectranetics Corporation Recall 90364 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1351-2022 |
| Event ID | 90364 |
| Event Description | Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM |
| Product Type | Devices |
| Distribution | US: AR AZ CA CO CT FL GA HI IA IL IN KS LA MA MD ME MI MN MO NC NJ NY OK PA TN TX VA OUS: Saudi Arabia, Denmark, France, Greece, India, Italy, Netherlands, Serbia, Spain, Sweden, United Kingdom |
| Quantity | 105 units |
| Recall Reason | The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared. |
| Device Classification | 20220720 |
| Device Code Info | Serial Numbers: 100000 to 100104 UDI/DI: (01)00813132027452 |
| Center Classification Date | 20220711 |
| Recall Initiation Date | 20220601 |
| Recalling Firm | Spectranetics Corporation |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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