FDA (Devices) recall action 64367
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance.
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.
Linvatec Corp. is recalling 31 D3000 Advantage Drive Systems because the front panel contains incorrect symbology, violating IEC60606-01 standards.
ConMed Linvatec is recalling 23 D3000I Advantage Drive Systems because the membrane switch panel contains incorrect symbology, violating IEC60606-01 standards.