Fujifilm Recalls Mammography Software Due to Potential Image Overwrite Error
Fujifilm is recalling 71 units of the Fuji Computed Radiography Mammography Suite because a software error may cause new images to overwrite previous ones in the hospital system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device used for cancer diagnosis where a software error could lead to the loss or overwriting of diagnostic images. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 71 units of the Fuji Computed Radiography Mammography Suite (FCRMS) software. This software is used with specific Fuji Computed Radiography systems to generate digital mammographic images for the screening and diagnosis of breast cancer. The recall covers 68 domestic units and 3 foreign units distributed worldwide.
The recall was initiated because the acquisition workstation software may rarely assign the same unique ID number to a new set of images that was already assigned to a previous set. If an image with this duplicate ID error is transmitted to the Picture Archiving and Communication System (PACS), it may overwrite the image already stored on the PACS. This issue affects software versions V5.0, V5.1, V5.2, V6.0, V6.1, and V7.0.
Healthcare facilities using these systems should contact Fujifilm Medical Systems U.S.A., Inc. for instructions on how to resolve the issue. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm)…
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 363AWS. Released Software Versions: V5.1
- V6.0. Not Released Software Versions: V5.0
- V5.2
- V6.1
- V7.0.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Fujifilm Medical Systems U.S.A., Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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