Recall Z-2834-2018— LIEBEL-FLARSHEIM COMPANY LLC
Class II · Terminated
Class II FDA medical device recall by LIEBEL-FLARSHEIM COMPANY LLC, initiated 2017-02-27, terminated 2023-08-16. It names one FDA 510(k) clearance: K121838. 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..
- Recalling firm
- LIEBEL-FLARSHEIM COMPANY LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-27
- Terminated
- 2023-08-16
- Firm location
- Saint Louis, MO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.