ASPIRE Cristalle recall
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR…
Why was ASPIRE Cristalle recalled?
There was a case that the swivel arm went down unintentionally when it was moved up/down.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
FDR MS-3500 : S/N- 76221095 or earlier
- Product
- ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR…
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Quantity
- 15 US 1 OUS
- Distribution
- US Distribution and Internationally to Mexico.
- Recall date
- January 24, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)