Liebel-Flarsheim Direct Digital Imaging System recall: Software Issue
Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring…
Why was Liebel-Flarsheim Direct Digital Imaging System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product ID 750736 SHF-635RF, 750737 SHF-835RF
- Product
- Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring…
- Recalling firm
- LIEBEL-FLARSHEIM COMPANY LLC
- Quantity
- 28
- Distribution
- 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,
- Recall date
- August 29, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)