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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0437-2024

DRX Revolution Mobile X-Ray System

Publicado el 13 de diciembre de 2023 · Inicio del retiro: 2 de octubre de 2023

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Unexpected failure of electrical components within the CPI generator.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Carestream Health, Inc.
Distribuidor
Worldwide Distribution: US (Nationwide Distribution); and OUS (Foreign): Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Dominican Rep., Finland, France, Germany, Ghana, Great Britain, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Macau, Malaysia, Maldives, Mexico, Monaco, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Republic of Korea, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, & Vietnam.
Lote
Catalog No. 1019397, 1023423, 1030717, 1030725, 1044726, 1060177, 8608754, 1023415, 8610180, 8618894; UDI-DI (01)60889971019394(21)2185, (01)60889971019394(21)2186, (01)60889971019394(21)2187, (01)60889971019394(21)2193, (01)60889971019394(21)2194, (01)60889971019394(21)2195, (01)60889971019394(21)2196, (01)60889971019394(21)2200, (01)60889971019394(21)2203, (01)60889971019394(21)2204, (01)60889971019394(21)2205, (01)60889971019394(21)2206, (01)60889971019394(21)2207, (01)60889971019394(21)2208, (01)60889971019394(21)2209, (01)60889971019394(21)2210, (01)60889971019394(21)2213, (01)60889971019394(21)2217, (01)60889971019394(21)2218, (01)60889971019394(21)2221, (01)60889971019394(21)2227, (01)60889971019394(21)2232, (01)60889971019394(21)2233, (01)60889971019394(21)2235, (01)60889971019394(21)2236, (01)60889971019394(21)2237, (01)60889971019394(21)2240, (01)60889971019394(21)2243, (01)60889971019394(21)2247, (01)60889971019394(21)2248, (01)60889971019394(21)2249, (01)60889971019394(21)2250, (01)60889971019394(21)2251, (01)60889971019394(21)2252, (01)60889971019394(21)2253, (01)60889971019394(21)2259, (01)60889971019394(21)2264, (01)60889971019394(21)2265, (01)60889971019394(21)2266, (01)60889971019394(21)2267, (01)60889971019394(21)2270, (01)60889971019394(21)2271, (01)60889971019394(21)2272, (01)60889971019394(21)2273, (01)60889971019394(21)2274, (01)60889971019394(21)2275, (01)60889971019394(21)2276, (01)60889971019394(21)2277, (01)60889971019394(21)2278, (01)60889971019394(21)2279, (01)60889971019394(21)2280, (01)60889971019394(21)2281, (01)60889971019394(21)2282, (01)60889971019394(21)2283, (01)60889971019394(21)2284, (01)60889971019394(21)2285, (01)60889971019394(21)2286, (01)60889971019394(21)2287, (01)60889971019394(21)2289, (01)60889971019394(21)2290, (01)60889971019394(21)2291, (01)60889971019394(21)2292, (01)60889971019394(21)2293, (01)60889971019394(21)2294, (01)60889971019394(21)2295, (01)60889971019394(21)2299, (01)60889971019394(21)2300, (01)60889971019394(21)2302, (01)60889971019394(21)2303, (01)60889971019394(21)2305, (01)60889971019394(21)2306, (01)60889971019394(21)2307, (01)60889971019394(21)2308, (01)60889971019394(21)2309, (01)60889971019394(21)2310, (01)60889971019394(21)2311, (01)60889971019394(21)2312, (01)60889971019394(21)2314, (01)60889971019394(21)2316, (01)60889971019394(21)2317, (01)60889971019394(21)2318, (01)60889971019394(21)2319, (01)60889971019394(21)2320, (01)60889971019394(21)2321, (01)60889971019394(21)2322, (01)60889971019394(21)2323, (01)60889971019394(21)2324, (01)60889971019394(21)2325, (01)60889971019394(21)2326, (01)60889971019394(21)2327, (01)60889971019394(21)2335, (01)60889971019394(21)2355, (01)60889971019394(21)2356, (01)60889971019394(21)2357, (01)60889971019394(21)2358, (01)60889971019394(21)2359, (01)60889971019394(21)2367, (01)60889971019394(21)2368, (01)60889971019394(21)2369, (01)60889971019394(21)2370, (01)60889971019394(21)2371, (01)60889971019394(21)2372, (01)60889971019394(21)2373, (01)60889971019394(21)2374, (01)60889971019394(21)2375, (01)60889971019394(21)2376, (01)60889971019394(21)2378, (01)60889971019394(21)2379, (01)60889971019394(21)2380, (01)60889971019394(21)2381, (01)60889971019394(21)2382, (01)60889971019394(21)2383, (01)60889971019394(21)2388, (01)60889971019394(21)2389, (01)60889971019394(21)2392, (01)60889971019394(21)2394, (01)60889971019394(21)2395, (01)60889971019394(21)2396, (01)60889971019394(21)2397, (01)60889971019394(21)2398, (01)60889971019394(21)2399, (01)60889971019394(21)2400, (01)60889971019394(21)2401, (01)60889971019394(21)2402, (01)60889971019394(21)2403, (01)60889971019394(21)2404, (01)60889971019394(21)2405, (01)60889971019394(21)2406, (01)60889971019394(21)2408, (01)60889971019394(21)2409, (01)60889971019394(21)2410, (01)60889971019394(21)2411, (01)60889971019394(21)2412, (01)60889971019394(21)2413, (01)60889971019394(21)2414, (01)60889971019394(21)2415, (01)60889971019394(21)2416, (01)60889971019394(21)2417, (01)60889971019394(21)2418
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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