Z-2834-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 29, 2018
- Initiation Date
- February 27, 2017
- Termination Date
- August 16, 2023
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 28
Product Description
Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.
Reason for Recall
Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings.
Distribution Pattern
US Distribution to: AL, AZ, CA, CT, CO, FL GA, HI, IA, IL, ID, KS, KY, MD, MI, Michigan, MN, NC, NH, NV, NY, OK, OH, PA, SC, TN, TX, VA, WA, WI, and WV,
Code Information
Product ID 750736 SHF-635RF, 750737 SHF-835RF