Liebel-Flarsheim Hydra Vision Urology X-Ray System Recalled for Software Issue
Liebel-Flarsheim is recalling 313 Hydra Vision Urology X-Ray 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 injury has not yet been reported, fitting the High severity criteria for significant functional defects without confirmed adverse events.
Plain-English summary
Liebel-Flarsheim Company LLC is recalling 313 units of the Hydra Vision Urology X-Ray System (DR) 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, endourology, and minimal invasive urology/surgery.
The recall is driven by a discrepancy between the display and dosimeter readings. In the Child/Pediatric automatic exposure mode, the difference between these readings is in the range of 52-65%. In all other modes, the display deviated by less than 35% from the dosimeter readings. The affected product codes are 750732 SHF-635RF and 750733 SHF-835RF.
The 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. Consumers and healthcare facilities should contact Liebel-Flarsheim Company LLC for further instructions regarding the recall.
The recalled product
- Product
- Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) 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
- 313
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 : 750732 SHF-635RF
- 750733 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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