Olympus OER-Elite devices recalled with a notice on warnings and maintenance
Aizu Olympus is issuing a recall covering 6,578 OER-Elite units to inform customers about pertinent warnings and cautions, recommended maintenance schedules and repair training requirements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Scored 1 under the documentation criterion: the action restates existing warnings and maintenance guidance and identifies no product defect.
Plain-English summary
The Olympus OER-Elite is the subject of a recall action. The record lists model OER-Elite, UDI 04953170404047, and covers all serial numbers.
The stated purpose of the action is to inform existing affected device customers about pertinent warnings and cautions, existing recommended maintenance schedules, and that only properly trained personnel should conduct repairs and maintenance.
The record lists 6,578 units, distributed nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record describes a customer notification about existing instructions rather than a product defect, and reports no injuries. Facilities should follow the firm's instructions.
The recalled product
- Product
- Olympus OER-Elite
- Manufacturer
- Aizu Olympus Co., Ltd.
- Affected units
- 6,578
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model: OER-Elite
- UDI: 04953170404047
- Serial #: All
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Aizu Olympus Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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