The Recall Desk

FDA (Devices) recall action 80174

LIEBEL-FLARSHEIM COMPANY LLC recalled 2 products on 2018-08-29

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-08-29
Critical
0
Units
341

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2018-08-29

    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.

    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, endourolog
    Category
    Distribution
    30 states
  • HighFDA (Devices)··2018-08-29

    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.

    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, endouro
    Category
    Distribution
    30 states