Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450…
- Recall date
- June 30, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2778-2015
- FDA classification
- Class II
- Brand / firm
- Fujifilm Medical Systems U.S.A., Inc.
- Sold / distributed
- Distributed in the US and Canada.
Why it was recalled
The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.
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 Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
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