Fujifilm Medical System USA, Inc. Fuji Flash IIP and CR-IR346CL Consoles Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fuji Flash IIP and CR-IR346CL Consoles
Brand
Fujifilm Medical System USA, Inc.
Lot Codes / Batch Numbers
Versions A09-17 through A11-12
Products Sold
Versions A09-17 through A11-12
Fujifilm Medical System USA, Inc. is recalling Fuji Flash IIP and CR-IR346CL Consoles due to Software: Incorrect measurement of objects within a CR image. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software: Incorrect measurement of objects within a CR image
Recommended Action
Per FDA guidance
FujiFilm Medical Systems issued notification letter dated 5/5/04 via Certified Mail. Units will be field corrected with a revised software by a service representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026