The Recall Desk
ModerateFDA (Devices)·Z-0661-2018·Announced 2018-02-28

Fujifilm ASPIRE Cristalle Mammography Systems Recalled for Image ID Errors

Fujifilm is recalling ASPIRE Cristalle mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images in hospital systems.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software logic error that may cause image overwriting, which is a data integrity issue rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for moderate severity.

Plain-English summary

Fujifilm Medical Systems U.S.A., Inc. is recalling 71 units of the ASPIRE Cristalle Digital Mammography System (FDR MS-3500) and associated acquisition workstations. The recall affects 68 domestic units and 3 foreign units distributed worldwide. The affected software versions include V5.1, V5.2, V6.0, V6.1, and V7.0.

The recall is due to a potential failure in the ID number generation logic. In rare cases, the system may 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 a Picture Archiving and Communication System (PACS), it may overwrite the image already stored on the PACS.

This issue affects facilities using the affected Fujifilm mammography systems for screening and diagnosis of breast cancer. The source text does not specify specific actions for consumers or patients, but the recall is intended to address the software logic error to prevent data overwriting in medical imaging archives.

The recalled product

Product
ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is in
Manufacturer
Fujifilm Medical Systems U.S.A., Inc.
Category
Medical Device — Mammography System
Hazard

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)

  • 3000AWS. Released Software Versions: V5.1
  • V5.2
  • V6.0
  • V6.1
  • V7.0. Not Released Software Versions: V5.0.

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.

See all 4 products in this recall →

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