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FUJIFILM

FUJIFILM CORPORATION · Model BL-7000X · UDI-DI 04547410446081

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510(k) clearances

64,511

Adverse events (1 deaths)

Recalls

Facilities

Description

The BL-7000X Light Source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and video processor together with monitor, recorder and various peripheral devices

Recalls

Date	Firm	Reason
2024-08-21	Olympus Corporation of the Americas	It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.
2023-09-25	Aizu Olympus Co., Ltd.	Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo
2023-09-25	Aizu Olympus Co., Ltd.	Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo
2018-05-11	Olympus Corporation of the Americas	Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, m
2018-05-11	Olympus Corporation of the Americas	Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient
2016-06-20	Karl Storz Endoscopy	Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinocope and an electro-surger
2015-06-30	Fujifilm Medical Systems U.S.A., Inc.	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
2015-06-30	Fujifilm Medical Systems U.S.A., Inc.	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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.