Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope fo…
- Recall date
- March 9, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3129-2017
- FDA classification
- Class II
- Brand / firm
- Fujifilm Medical Systems U.S.A., Inc.
- Sold / distributed
- US Nationwide Distribution
Why it was recalled
Fujifilm is conducting a corrective action due to an FDA inspection.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
Get recall alerts
Free email alert whenever Fujifilm Medical Systems U.S.A., Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Fujifilm Medical Systems U.S.A., Inc.