FDA Device recall Z-0385-2018
Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography ma…
- FDA Device
- Class II
- terminated
- Published 2018-01-24
On 2018-01-24 the FDA classified a Class II recall of Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography ma… by Fujifilm Medical Systems U, citing there was a case that the swivel arm went down unintentionally when it was moved up/down.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0385-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-14 |
| Published | 2018-01-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | n/a |
Product
Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). 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 of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
Reason
There was a case that the swivel arm went down unintentionally when it was moved up/down.
Identifiers
| code_info | FDR MS-2500 made in Japan : S/N- 16640001 or later FDR MS-2500 made in China : S/N- 26860001 or later FDR MS-2000 m…FDR MS-2500 made in Japan : S/N- 16640001 or later FDR MS-2500 made in China : S/N- 26860001 or later FDR MS-2000 made in Japan : S/N- 16650001 or later FDR MS-2000 made in China : S/N- 26870001 or later |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Fujifilm Medical Systems U
- Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
FDA Device · Class II · 2021-06-09 · Fujifilm Medical Systems U - ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
FDA Device · Class II · 2021-04-21 · Fujifilm Medical Systems U - Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC m…
FDA Device · Class II · 2021-04-14 · Fujifilm Medical Systems U - FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf P…
FDA Device · Class II · 2021-02-03 · Fujifilm Medical Systems U - Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high densi…
FDA Device · Class III · 2021-02-03 · Fujifilm Medical Systems U
All Fujifilm Medical Systems U recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0385-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.