Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound recall — FDA D-0773-2026
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Overview of recall records associated with Liebel-Flarsheim Company LLC, including dates, categories and classifications where available.
Classification mix: Class II: 3, Class I: 1.
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
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…
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…
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…
This page summarizes recall records in which the official source identifies Liebel-Flarsheim Company LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.