FDA (Devices) recall action 98768
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 the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
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.
HarmonyAIR A-Series Surgical Lighting Systems are being recalled because the plus and minus buttons used to control light intensity on the light heads may detach. 2,101 units affected.
ALYON Surgical Lighting Systems are being recalled because the plus and minus buttons used to control light intensity on the light heads may detach. 549 units are affected.