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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 OERPRO, would not meet the current FDA guidance for reprocessing validation without further design changes. An ineffectively reprocessed endoscope can present an infection control risk to patients. As a result, OMSC is revising the OER-PRO labelling such that the GF-UC140PAL5 is no longer a compatible endoscope for reprocessing in the OER-PRO. Olympus has not received any reported complaints of infection associated with the GFUC140P-AL5 when reprocessed in the OER-PRO.
Recall start date: Mar 18, 2022
Olympus Medical Systems Corp.
2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To