[Recalled] 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-f
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| 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 screening and diagnosis o |
|---|---|
| Brand / manufacturer | Fujifilm Medical Systems U.S.A., Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0386-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 14 July 2017 |
| EAN / barcode | 76221095 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: There was a case that the swivel arm went down unintentionally when it was moved up/down.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Fujifilm Medical Systems U.S.A., Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.