FDA Device recall Z-2834-2018
Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures…
- FDA Device
- Class II
- terminated
- Published 2018-08-29
On 2018-08-29 the FDA classified a Class II recall of Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures… by Liebel Flarsheim, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2834-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-27 |
| Published | 2018-08-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Liebel Flarsheim |
| Distribution | AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, MI, MN, NC, NH, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV |
Product
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
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.
Identifiers
| code_info | Product ID 750736 SHF-635RF, 750737 SHF-835RF |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2834-2018%22
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