ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
Reported: January 24, 2018 Initiated: July 14, 2017 #Z-0386-2018
Product Description
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
Reason for Recall
There was a case that the swivel arm went down unintentionally when it was moved up/down.
Details
- Recalling Firm
- Fujifilm Medical Systems U.S.A., Inc.
- Units Affected
- 15 US 1 OUS
- Distribution
- US Distribution and Internationally to Mexico.
- Location
- Stamford, CT
Frequently Asked Questions
What product was recalled? ▼
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.. Recalled by Fujifilm Medical Systems U.S.A., Inc.. Units affected: 15 US 1 OUS.
Why was this product recalled? ▼
There was a case that the swivel arm went down unintentionally when it was moved up/down.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2018. Severity: Moderate. Recall number: Z-0386-2018.
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