Z-0386-2018 Class II Terminated
FDA device recall Z-0386-2018 was initiated by Fujifilm Medical Systems U.S.A., Inc. on Jul 14, 2017 and is designated Class II. Reason for recall: There was a case that the swivel arm went down unintentionally when it was moved up/down. The recall status is terminated (terminated Jul 20, 2018). Affected quantity: 15 US 1 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 24, 2018
- Initiation Date
- Jul 14, 2017
- Termination Date
- Jul 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 US 1 OUS
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.
Distribution Pattern
US Distribution and Internationally to Mexico.
Code Information
FDR MS-3500 : S/N- 76221095 or earlier
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0386-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026