Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.
Reported: May 13, 2015 Initiated: February 3, 2015 #Z-1585-2015
Product Description
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.
Reason for Recall
User Manual lacks a description for handling some errors even though the system can be recovered from such errors
Details
- Recalling Firm
- Fujifilm Medical Systems U.S.A., Inc.
- Units Affected
- 1 unit
- Distribution
- Distributed in HI.
- Location
- Stamford, CT
Frequently Asked Questions
What product was recalled? ▼
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.. Recalled by Fujifilm Medical Systems U.S.A., Inc.. Units affected: 1 unit.
Why was this product recalled? ▼
User Manual lacks a description for handling some errors even though the system can be recovered from such errors
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2015. Severity: Moderate. Recall number: Z-1585-2015.
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