Liebel-Flarsheim Direct Digital Imaging System Recalled for Software Display Discrepancy
Liebel-Flarsheim is recalling 28 Direct Digital Imaging Systems due to a software issue causing significant discrepancies between display and dosimeter readings in pediatric modes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where significant measurement discrepancies could lead to improper radiation exposure, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Liebel-Flarsheim Company LLC is recalling 28 units of the Direct Digital Imaging System (DDIS) due to a software issue. The affected systems are used for radiologic and fluoroscopic procedures, primarily for urological applications such as functional x-ray diagnostics and endourology.
The recall is triggered by a discrepancy between the display readings and the dosimeter readings. In the Child/Pediatric automatic exposure mode, the difference between these readings ranges from 52% to 65%. In all other modes, the display deviated by less than 35% from the dosimeter readings.
The affected units were distributed to facilities in Alabama, Arizona, California, Connecticut, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Idaho, Kansas, Kentucky, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, Nevada, New York, Oklahoma, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, and West Virginia. Product IDs associated with the recall are 750736 (SHF-635RF) and 750737 (SHF-835RF).
The recalled product
- 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…
- Manufacturer
- LIEBEL-FLARSHEIM COMPANY LLC
- Affected units
- 28
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product ID 750736 SHF-635RF
- 750737 SHF-835RF
Distribution
Part of a larger recall action
This product is one of 2 recalled by LIEBEL-FLARSHEIM COMPANY LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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