Aizu Olympus recalled 6,578 OER-Elite medical devices distributed nationwide in the United States. The recall cites warnings, cautions, and maintenance requirements and says only trained personnel should perform repairs. Healthcare providers and patients should stop using the device and await recall instructions from the manufacturer.
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Aizu Olympus Co., Ltd. or your healthcare provider for instructions. Notification method: Letter
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The OER-Elite is a medical device manufactured by Aizu Olympus Co. It is used in clinical settings under professional supervision.
The hazard centers on warnings, cautions, and maintenance schedules. Only trained personnel should perform repairs and maintenance, and users should stop using the device until further notice.
This recall is not indicated to be part of a broader industry pattern.
Active recall with nationwide distribution means facilities and patients must halt use and await instructions. No injuries reported in the notice.
Check the device label, packaging, and the FDA enforcement recall page provided in the notice.
Timeline for remedy is not specified in the recall notice.
Retain the recall notice, device labels showing model and UDI, and all correspondence with the manufacturer and healthcare providers.
Model: OER-Elite; UDI: 04953170404047; Serial #: All; Sold in: United States nationwide; Sold from: Unknown; Price: Unknown; Quantity: 6578; Recall date: 2025-10-31; Manufacturer: Aizu Olympus Co.
No injuries or incidents have been reported.
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