Z-0569-2021 Class II Terminated
FDA device recall Z-0569-2021 was initiated by Ra Medical Systems, Inc. on October 16, 2020 and is designated Class II. Reason for recall: Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the… The recall status is terminated (terminated January 11, 2023). Affected quantity: 36 devices.
Recall Details
- Product Type
- Devices
- Report Date
- December 23, 2020
- Initiation Date
- October 16, 2020
- Termination Date
- January 11, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 devices
Product Description
DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
Reason for Recall
Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase.
Distribution Pattern
US Distribution to states of: AL, AZ, CA, FL, IL, IN, KY, LA, MD, NC, NV, NY, OK, OR, TX, and WA; and to OUS country: Japan.
Code Information
Model Number RA-308 Product/Catalog Number: 1200-0001-01 Serial Numbers: RA00027, RA00046, RA00049, RA00050, RA00054, RA00056, RA00057, RA00058, RA00064, RA00069, RA00073, RA00081, RA00083, RA00084, RA00085, RA00089, RA00097, RA00098, RA00114, RA00115, RA00120, RA00121, RA00125, RA00127, RA00135, RA00138, RA00148, RA00153, RA00154, RA00160, RA00164, RA00165, RA00167, RA00170, RA00175, and RA00177.