The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the amount of electrical current flowing to the earth is within standard limits
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Germany, Hong Kong.
The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
Class IIReported ongoing
Distribution: US Nationwide distribution in the state of NY.
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.
Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifi...
Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifi...
The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
These examples come from this result page and are not a ranking of every recall reason.
Checking Olympus Corporation of the Americas
Is there a recall on olympus corporation of the americas right now?
This archive contains 327 records, including 323 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
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Where can I find older records?
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.