Olympus Corporation of the Americas recalls EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch…
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…
Read the official notice →- Date
- 2024-07-10
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Germany, Hong Kong.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Olympus Corporation of the Americas recalls
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USOlympus Corporation of the Americas recalls The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer…
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Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - 2024-07-31
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Olympus Corporation of the Americas recalls ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of…
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Olympus Corporation of the Americas recalls OES 4000 Hysteroscope, Model/Catalog Number: A4674A
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.
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution in the state of NY.Official notice → - 2024-05-29
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FDA · DeviceOlympus Corporation of the AmericasDomestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan.Official notice → - 2024-05-08
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FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.Official notice →
Other drugs & medical recalls in the United States
- 2024-07-10
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Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro…
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SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product…
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