Steris Corporation: HarmonyAIR A-Series Surgical Lighting System

Hazard

There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.

Details from the source

Reason for recall: There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama. Quantity: 4138 units Lot/code info: UDIs: 00724995186388, 00724995186401, 00724995188320, 00724995188481, 00724995188467, 00724995188498, 00724995189433, 00724995186562, 00724995188696, 00724995188627, 00724995188610, 00724995186074, 00724995186081, 00724995186302, 00724995186319, 00724995188269, 00724995186371, 00724995188634, 00724995186326, 00724995186067, 00724995186548, 00724995186579, 00724995188580, 00724995187149, 00724995187170, 00724995187989, 00724995187644, 00724995188337, 00724995189297, 00724995188313, 00724995186128, 00724995188689, 00724995188252, 00724995188474, 00724995188597, 00724995188221, 00724995189174, 00724995188276, 00724995186180, 00724995189143 00724995186111, 00724995186340, 00724995187224, 00724995189075, 00724995188306 00724995188603, 00724995189051, 00724995200954, 00724995200022, 00724995199906 00724995190033, 00724995186678, 00724995188351, 00724995188665, 00724995187996 00724995189068, 00724995189099, 00724995189150, 00724995199869, 00724995187385 00724995187347, 00724995200886, 00724995190361, 00724995200893, 00724995200916 00724995186333, 00724995187026, 00724995187262, 00724995186715, 00724995186746 00724995188283, 00724995187279, 00724995186135, 00724995188511, 00724995188009, 00724995188245, 00724995189310, 00724995186555, 00724995188504, 00724995187033 00724995190354, 00724995188238, 00724995186739, 00724995188290, 00724995199890, 00724995187156, 00724995187187, 00724995187521, 00724995187552, 00724995186142, 00724995186647, 00724995185985, 00724995186104, 00724995187781

UPC codes

00724995186388, 00724995186401, 00724995188320, 00724995188481, 00724995188467, 00724995188498, 00724995189433, 00724995186562, 00724995188696, 00724995188627, 00724995188610, 00724995186074, 00724995186081, 00724995186302, 00724995186319, 00724995188269, 00724995186371, 00724995188634, 00724995186326, 00724995186067, 00724995186548, 00724995186579, 00724995188580, 00724995187149, 00724995187170, 00724995187989, 00724995187644, 00724995188337, 00724995189297, 00724995188313, 00724995186128, 00724995188689, 00724995188252, 00724995188474, 00724995188597, 00724995188221, 00724995189174, 00724995188276, 00724995186180, 00724995189143

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.