The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal Imager has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging)
Check against the official notice below — it lists the full affected range.
Merge Healthcare has recalled 1,252 units of the WinStation Retinal Imager (also known as Merge Eye Station), models DCF-1024 and DCF-512, distributed nationwide. Certain configurations of this retinal imaging device may produce electrical output exceeding allowable limits for medical devices, with leakage current found to exceed safe limits in earth leakage current, touch current, and patient leakage current under single fault conditions involving an open ground.
The affected units are identified by UDI 00842000100140 and multiple serial numbers listed in the recall record. The recall affects devices distributed across all U.S. states and the District of Columbia. The source document does not specify what actions consumers or healthcare facilities should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allowable limits in earth leakage current, touch current in a single fault condition (of open ground) and patient leakage current in a single fault condition (of open ground).
Reason for recall: Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allowable limits in earth leakage current, touch current in a single fault condition (of open ground) and patient leakage current in a single fault condition (of open ground). Distribution: Distribution nationwide to Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, , Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Orego Quantity: 1,252 Units Lot/code info: UDI: 00842000100140. Serial Numbers: a0L3200000BVmMo, a0L3200000DyTSA, a0L3200000AiuLX, a0L3200000BUou2, a0L0e00000EPuiz, a0L3200000BVZ7i, a0L3200000Ajd0n, a0L3200000C04Ol, a0L3200000Aj6EX, a0L32000009gkeu, a0L3200000BUOXv, a0L3200000Aj6TP, a0L3200000BTnqr, a0L3200000AjTBg, a0L32000008q1mk, a0L0e00000DzQ3a, a0L3200000B2Csy, a0L32000009hJZk, a0L32000009n0mi, a0L0e00000E0aFN, a0L3200000DyFdA, a0L0e00000EPw0a, a0L3200000C03vm, a0L3200000DyF4P, a0L3200000AjY5P, a0L32000009n1Mk, a0L3200000B1MV5, a0L0e00000EPw6s, a0L32000008qtIF, a0L3200000BVzZ6, a0L3200000BTLiZ, a0L3200000Aj6bv, a0L0e00000E0C04, a0L3200000AihSR, a0L3200000AihUh, a0L3200000BUc9x, a0L3200000BUcAH, a0L32000009hLmm, a0L3200000AivBM, a0L3200000AjYPs, a0L32000009h8o4, a0L0e00000E07hv, a0L32000008quuk, a0L3200000DyNRS, a0L3200000B19Jt, a0L3200000B0uso, a0L0e00000E0CSc, a0L3200000B09PT, a0L3200000B09PJ, a0L3200000B09Pd, a0L3200000BTlfb, a0L3200000DiqQx, a0L32000009hJrd, a0L32000009mlt9, a0L32000009md53, a0L32000009nTWm, a0L0e00000EPxQj, a0L3200000BWKuB, a0L3200000B1N0q, a0L3200000Dyg4I, a0L0e00000Dzwru, a0L3200000BzVK2, a0L3200000AjnnW, a0L3200000DySwx, a0L3200000BgdOF, a0L32000009h6WM, a0L32000009h6WR, a0L3200000B0CXr, a0L3200000Aitxy, a0L32000009hJ6P, a0L3200000DyGJu, a0L60000007LRa6, a0L3200000DyFXC, a0L60000007OcXf, a0L3200000AjkWQ, a0L3200000Di2CQ, a0L3200000BWZGK, a0L0e00000Dkz6R, a0L3200000AjbF3, a0L3200000DyGL3, a0L3200000DyGKd, a0L3200000DyGKs, a0L3200000BTYBz, a0L3200000AjSo7, a0L3200000AjmbA, a0L0e00000DxTju, a
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.