Carestream Health, Inc.: DRX Revolution Mobile X-Ray System

Hazard

Unexpected failure of electrical components within the CPI generator.

Details from the source

Reason for recall: Unexpected failure of electrical components within the CPI generator. Distribution: 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, Monac Quantity: 3,961 units Lot/code info: 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(

UPC codes

60889971019394

Source

Official record: FDA (Device enforcement) ↗

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