Reported Aug 29, 2018 · Terminated
Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or…
Liebel-Flarsheim Company LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LIEBEL-FLARSHEIM COMPANY LLC · 1034 S Brentwood Blvd · Saint Louis, MO · 63117-1223
Is this the product you have?
- 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, endourology and minimal invasive urology/ surgery.
- Lot codes and dates
- Product ID
750732 SHF-635RF750733 SHF-835RF
- Product ID
- Amount recalled
- 313
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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