ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500
FDA device recall Z-0386-2018 · posted 2018-01-17 · Terminated
Recall details
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Reason for recall
- There was a case that the swivel arm went down unintentionally when it was moved up/down.
- Action taken
- FUJIFILM sent an Urgent: Medical Device Correction Letter dated July 14, 2017, accompanied by a Customer Feedback form to customers. PLEASE READ AND FOLLOW THE INSTRUCTIONS Please refer to the following page which provides the details of the problem and instructions for actions to be taken. Please follow the instructions in the ACTIONS TO BE TAKEN BY CUSTOMER/USER section. We sincerely regret the inconvenience that this may cause you. FUJIFILM is committed to providing products and services of the highest quality. Your satisfaction with FUJIFILM products and with our response to this issue is very important to us. If you have any questions about this matter, please contact your local FUJIFILM office. For further questions, please call (360) 356-6821.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MUE
- Quantity affected
- 15 US 1 OUS
- Distribution
- US Distribution and Internationally to Mexico.
- Date initiated
- 2017-07-14
- Date posted
- 2018-01-17
- Date terminated
- 2018-07-20
- Location
- Stamford, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ASPIRE CRISTALLE (K133972) | Fujifilm Medical Systems U.S.A, Inc. | 2014-03-25 |