Recall Z-0050-2021
Ra Medical Systems, Inc. · initiated July 24, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
Codes / lots: Model Number DABRA Excimer Laser RA-308; Serial Numbers: RA00027, RA00039, RA00046, RA00049, RA00050, RA00054, RA00055, RA00056, RA00057, RA00058, RA00063, RA00064, RA00065, RA00067, RA00069, RA00070, RA00073, RA00074, RA00081, RA00082, RA00083, RA00084, RA00085, RA00086, RA00088, RA00089, RA00097, RA00098, RA00103, RA00114, RA00115, RA00117, RA00118, RA00120, RA00121, RA00124, RA00125, RA00127, RA00135, RA00136, RA00137, RA00138, RA00143, RA00147, RA00148, RA00153, RA00154, RA00160, RA00164, RA00165, RA00167, RA00170, RA00175, and RA00177.
Reason for recall
Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
FDA-determined cause: Device Design
Action taken
On August 10, 2020, the firm sent an "Urgent Medical Correction" letter to customers, informing them of the incorrect laser wheel size, which upon moving or adjusting the laser with the wheels in locked position may fall over. If this were to happen during a medical procedure, user or patient injury may occur.
Details
- Recall number
- Z-0050-2021
- Initiated
- July 24, 2020
- Terminated
- August 9, 2023
- Product code
- PDU – Catheter For Crossing Total Occlusions
- Quantity
- 54 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, ID, IL, IN, KS, KY, LA, MA, MD, MI, NC, NV, NY, OR, OK, PA, TX, WA and the country of Japan.
- Recalling firm
- Ra Medical Systems, Inc., Carlsbad, CA