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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