DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and
FDA device recall Z-2497-2020 · posted 2020-07-04 · Terminated
Recall details
- Recalling firm
- Ra Medical Systems, Inc.
- Reason for recall
- A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.
- Action taken
- The Urgent Medical Device Correction notification was sent as certified mail USPS letter to consignees on 1/31/2020. The requested actions are as follows: 1. Do not use the excimer laser until a service technician has installed the new version of software to correct the issue. 2. Complete and return the acknowledgement form, whether you have any of the affected product or not, indicating: * Whether you have the excimer laser in question at your facility, *If you do have the excimer laser, the physical address where the product is located; and, *The person to be contacted to schedule a service call to correct the issue. Should you have any questions or need further assistance call (442) 325-5044.
- Root cause
- Software design
- Status
- Terminated
- Product code
- PDU
- Quantity affected
- 79 units
- Distribution
- US: AL, AZ, CA, FL, GA, ID, IL, IN, KS, KY, LA, MI, MD, NC, NV, NY, OK, OR, PA, TN,TX, WI. OUS: Italy and Japan.
- Date initiated
- 2020-01-23
- Date posted
- 2020-07-04
- Date terminated
- 2021-11-01
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RA-308 Excimer Laser System, Excimer Laser Catheter (K170349) | Ra Medical Systems,Inc | 2017-05-24 |