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Brand: OLYMPUS MEDICAL SYSTEMS CORP.
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Displaying 1 - 5 of 5 items.
Disposable Rotatable Clip Fixing Device
Olympus has received complaints that the clip did not come out of the tube sheath during the procedure. investigation by Olympus confirmed the tube sheath is longer than specifications which prevents the clip from being extended. Absence of treatment,…
RecallHealth product recall | 2023-03-17
Disposable Grasping Forceps
Olympus has received complaints that the grasping portion of FG-51D forceps can be difficult to open and close. Olympus reviewed approximately 200 complaints globally over the last five years. Subsequent complaint investigation has confirmed that the FG-…
RecallHealth product recall | 2022-04-11
Ultrasonic Gastrovideoscope
Olympus Medical Systems Corp (OMSC) conducted a postmarket risk assessment of the GFUC140P-AL5. As part of that review, OMSC applied updated FDA guidance for reprocessing validation. OMSC's testing showed that the GF-UC140P-AL5, when reprocessed in the…
RecallHealth product recall | 2022-04-04
Oer-Elite Automated Endoscope Reprocessor
The OER-elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Olympus discovered the detergent and alcohol tank tubing…
RecallHealth product recall | 2021-12-31
Duodenovideoscope
Olympus previously introduced an annual TJF-Q180V inspection program whereby users are asked to return the TJF-Q180Vs in their possession for inspection. Olympus has reviewed the data obtained via this program and has observed deterioration of the TJF-…
RecallHealth product recall | 2021-12-02