Z-2834-2018Class II

Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic...

Name: Z-2834-2018 Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic...
Creator: Liebel-Flarsheim Company Llc
Published: 2017-02-27
License: https://open.fda.gov/license/

Mallinckrodt, Inc. / initiated 2017-02-27 / Terminated / root cause: software

FDA source

LIEBEL-FLARSHEIM COMPANY LLC began a recall of Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of... on 2017-02-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2834-2018
Classification: Class II
Status: Terminated
Initiated: 2017-02-27
Posted: 2018-08-21
Terminated: 2023-08-16
Recalling firm: Mallinckrodt, Inc.
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.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: The firm, Liebel-Flarsheim, notified its customers by phone on or about 2/27/2017 to inform them of the product, problem and actions to be taken. The firm plans to have these Sedecal software updates implemented over the course of the next 12 months. For additional information, please contact me at 314-376-4788.
Quantity in commerce: 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,
Product codes and lots: Product ID 750736 SHF-635RF, 750737 SHF-835RF

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2834-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2833-2018	Class II	Terminated	FDA Mandated	2018-08-29	2018-08-21
Z-2834-2018	Class II	Terminated	FDA Mandated	2018-08-29	2018-08-21

Product code MQB

K121838Class IILiebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim / cleared 2012-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)