FDA (Devices) recall action 80628
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.
The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system.
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.
Pro-Med Instruments is recalling 30 DORO LUCENT Headrest Systems because mixing design revisions may cause malfunction during surgery.
Pro-Med Instruments is recalling 31 DORO LUCENT Locking Transitional Members because mixing design revisions may cause the headrest system to malfunction.
Pro-Med Instruments is recalling 31 DORO LUCENT Transitional Members because mixing design revisions may cause the headrest system to malfunction.