Fujifilm Aspire Cristalle Mammography Machine Recalled for Swivel Arm Defect
Fujifilm is recalling Aspire Cristalle mammography machines because the swivel arm may move down unintentionally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a mechanical defect in a medical device that poses a risk of harm (injury), but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling the ASPIRE Cristalle (FDR MS-3500) mammography machine. The recall involves 15 units in the United States and 1 unit in Mexico.
The recall is being issued because there was a case where the swivel arm went down unintentionally when it was moved up or down. This defect could pose a risk of injury to patients or operators.
Affected units are identified by serial number 76221095 or earlier. Users of these devices should contact Fujifilm Medical Systems U.S.A., Inc. for further instructions on how to address the issue.
The recalled product
- Product
- 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 scree
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- FDR MS-3500 : S/N- 76221095 or earlier
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Fujifilm Medical Systems U.S.A., Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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