Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to obser
FDA device recall Z-2806-2015 · posted 2015-09-22 · Terminated
Recall details
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Reason for recall
- 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.
- Action taken
- Fujifilm Medical Systems USA, Inc. initiated this recall by sending a Voluntary Field Correction Letter and Tracking/Verification Form dated June 30, 2013 to their affected customers.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FET
- Quantity affected
- multiple
- Distribution
- Nationwide US and Canada
- Date initiated
- 2015-06-30
- Date posted
- 2015-09-22
- Date terminated
- 2017-05-25
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM (K944759) | Fujinon, Inc. | 1995-04-11 |