FDAFDA · Food and drugs·Recall number Z-0437-2024
DRX Revolution Mobile X-Ray System
Published December 13, 2023 · Recall initiated: October 2, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Unexpected failure of electrical components within the CPI generator.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carestream Health, Inc.
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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