Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), 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 intended for use in the same clinical applications as traditional screen-film mammography systems.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1000AWS. Released Software Versions: V5.0, V5.1. Not Released Software Versions: V5.2, V6.0, V6.1, V7.0.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Fujifilm Medical Systems U.S.A., Inc.
- Reason for Recall:
- FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), 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 intended for use in the same clinical applications as traditional screen-film mammography systems.
Product Codes/Lot Numbers:
1000AWS. Released Software Versions: V5.0, V5.1. Not Released Software Versions: V5.2, V6.0, V6.1, V7.0.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0659-2018
Related Recalls
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Fujifilm Medical Systems U.S.A.
Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Fujifilm Medical Systems U.S.A.
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
Fujifilm Medical Systems U.S.A.
The wrong patient information may be displayed in the viewer or PowerJacket.