FDA Device recall Z-2805-2015
Fujinon/Fujifilm Processor EPX 2500 Operation Manual
- FDA Device
- Class II
- terminated
- Published 2015-09-30
On 2015-09-30 the FDA classified a Class II recall of Fujinon/Fujifilm Processor EPX 2500 Operation Manual by Fujifilm Medical Systems U, citing the EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2805-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-30 |
| Published | 2015-09-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | US |
Product
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
Reason
The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT endoscope is used with the 2500 processor, a "super image" is displayed when it is actually a "standard image" that is displayed.
Identifiers
| code_info | Part Numbers: 202B1230408A, 202B1230408B, 202B1230408C, 202B1230408D and 202B1230408E |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2805-2015%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.