Home / Brands / Liebel-Flarsheim
Liebel-Flarsheim Recalls
4 recalls on record · August 29, 2018 to August 19, 2026 · Drugs, Medical Devices
Recalls by year
18
21
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 19, 2026DrugsFDA
Liebel-Flarsheim Company LLC recalls Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial,
Hazard: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
July 14, 2021Medical DevicesFDA
LIEBEL-FLARSHEIM COMPANY LLC recalls HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Hazard: Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ¿ 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.
August 29, 2018Medical DevicesFDA
LIEBEL-FLARSHEIM COMPANY LLC recalls Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or
Hazard: 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.
August 29, 2018Medical DevicesFDA
LIEBEL-FLARSHEIM COMPANY LLC recalls Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/
Hazard: 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.