FDA (Devices) recall action 97849
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
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.
Aizu Olympus is issuing a recall covering 6,578 OER-Pro units to inform customers about pertinent warnings and cautions, recommended maintenance schedules and repair training requirements.
Aizu Olympus is issuing a recall covering 6,578 OER-Mini units to inform customers about pertinent warnings and cautions, recommended maintenance schedules and repair training requirements.