Centricity PACS-IW recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a) 2041037-001, No UDI/DI, Product ID Numbers: 4443-1-Centricity PACS-IW-00558167; b) 2042988-001, No UDI/DI, Product ID Numbers: 707509-Centricity PACS-IW-01452391, 613493-Centricity PACS-IW-02292544, SiteID-Centricity PACS-IW-01572187; c) 2049587-009, No UDI/DI, Product ID Numbers: 1402-7-Centricity PACS-IW-18957305, 1402-7-Centricity PACS-IW-19265438, 1402-7-Centricity PACS-IW-18166109, 1402-7-Centricity PACS-IW-18166110, 1402-2-Centricity PACS-IW-18984905, 1402-2-Centricity PACS-IW-18985934, 1402-2-Centricity PACS-IW-19031647, 1402-1-Centricity PACS-IW-17192703, 1402-1-Centricity PACS-IW-17192704, 1402-1-Centricity PACS-IW-00558291, 4276-1-Centricity PACS-IW-00558274, 12974-1-Centricity PACS-IW-00558300, 4482-1-Centricity PACS-IW-00558281, BA4080-Centricity PACS-IW-00038769, 320090-Centricity PACS-IW-01444604, HOLY-FAMILY-THODU-Centricity PACS-IW-01821493, RU3382-Centricity PACS-IW-01273247, RU3680-Centricity PACS-IW-01273260, RU3380-Centricity PACS-IW-01273246; d) 2049587-011, No UDI/DI, Product ID Numbers: 12830-1-Centricity PACS-IW-00558312, 4352-1-Centricity PACS-IW-00558316, PL1825-Centricity PACS-IW-00038819, 14335625-Centricity PACS-IW-20614918; e) 2049587-012, No UDI/DI, Product ID Numbers: 100858-1-Centricity PACS-IW-00558426, 4109-1-Centricity PACS-IW-00558389, 4294-1-Centricity PACS-IW-00558379, 13039-1-Centricity PACS-IW-00558385, 101742-1-Centricity PACS-IW-00558470, 9791-1-Centricity PACS-IW-00558418, 11764-1-Centricity PACS-IW-00558388, 101689-1-Centricity PACS-IW-00558326, 4744-1-Centricity PACS-IW-00558373, 4374-1-Centricity PACS-IW-00558422, 4277-1-Centricity PACS-IW-00558474, 101216-1-Centricity PACS-IW-00558356, 101240-1-Centricity PACS-IW-00558425, 4361-1-Centricity PACS-IW-00558343, 12949-1-Centricity PACS-IW-00558442, 4393-1-Centricity PACS-IW-00558328, 100645-1-Centricity PACS-IW-14764451, 4573-1-Centricity PACS-IW-00558420, 4506-1-Centricity PACS-IW-00558345, AZ4030-Centricity PACS-IW-02336621, 324462-Centricity PACS-IW-01431554, 246838-Centricity PACS-IW-01421153, 280801-Centricity PACS-IW-01431490, 307319-Centricity PACS-IW-01444609, StThomas-Centricity PACS-IW-01819447, WOCKHARDT-Centricity PACS-IW-01819449, SIMS-Centricity PACS-IW-01819453, MARTHANDAM-Centricity PACS-IW-01819446, CONTINENTAL-Centricity PACS-IW-01819443, KW1112-Centricity PACS-IW-00168151, BEVERLY-Centricity PACS-IW-01288659, MAHKOTA-Centricity PACS-IW-01286179, UMUM-Centricity PACS-IW-01288666, RU2580-Centricity PACS-IW-01273240, ONCOLOGY-Centricity PACS-IW-01288658; f) 2049587-015, No UDI/DI, Product ID Numbers: 4345-1-Centricity PACS-IW-00558548, 101792-1-Centricity PACS-IW-00558370, 4378-1-Centricity PACS-IW-00558498, 100663-1-Centricity PACS-IW-00558514, 100702-1-Centricity PACS-IW-00558539, 101625-1-Centricity PACS-IW-00558531, 4593-1-Centricity PACS-IW-00558488, 100009-1-Centricity PACS-IW-00558560, 100838-1-Centricity PACS-IW-00558532, 13102-1-Centricity PACS-IW-00558512, 4694-1-Centricity PACS-IW-00558556, 101883-1-Centricity PACS-IW-00558487, 4358-1-Centricity PACS-IW-00558564, 13095-1-Centricity PACS-IW-00558534, 4326-4-Centricity PACS-IW-00558105, 4301-1-Centricity PACS-IW-00558525, 2387-1-Centricity PACS-IW-00558489, 100802-1-Centricity PACS-IW-00558540, 101193-1-Centricity PACS-IW-00558551, 4661-1-Centricity PACS-IW-00558528, 3943-1-Centricity PACS-IW-00558501, 4383-1-Centricity PACS-IW-00558533, 13233-3-Centricity PACS-IW-00558554, 4389-1-Centricity PACS-IW-00558563, 302144-Centricity PACS-IW-01421157, 213537-Centricity PACS-IW-01431510, 319674-Centricity PACS-IW-01431535, RMUE01-Centricity PACS-IW-00001801, A2513980-Centricity PACS-IW-00040355, KW1019-Centricity PACS-IW-00115173, KW1018-Centricity PACS-IW-01422962, KW1003-Centricity PACS-IW-01798078, KW1001-Centricity PACS-IW-00164288, SSH-Centricity PACS-IW-01288660, PL2997-Centricity PACS-IW-00038793, PL1803-Centricity PACS-IW-00038812, PL1006-Centricity PACS-IW-00038821, PL1822-Centricity PACS-IW-00038825, TBD-Centricity PACS-IW-01273193, RU1241-Centricity PACS-IW-01273216, RU1493-Centricity PACS-IW-01273220, TBD-Centricity PACS-IW-01273244, RU2420-Centricity PACS-IW-01273234, RU3262-Centricity PACS-IW-01273245, RU6248-Centricity PACS-IW-01273279, RU8052-Centricity PACS-IW-02337508, RU8071-Centricity PACS-IW-01273295, -Centricity PACS-IW-01273233, RU7576-Centricity PACS-IW-01273287, RU3880-Centricity PACS-IW-01273266, RU2527-Centricity PACS-IW-01273235, RU2878-Centricity PACS-IW-01273243, TBD-Centricity PACS-IW-01273306, TBD-Centricity PACS-IW-01273258, RU5499-Centricity PACS-IW-01273278, RU1279-Centricity PACS-IW-02337628, RU1469-Centricity PACS-IW-01273219, TBD-Centricity PACS-IW-01273200, RU8321-Centricity PACS-IW-01273303, RU1130-Centricity PACS-IW-01273210, RU7426-Centricity PACS-IW-01273284, TBD-Centricity PACS-IW-01273262, TBD-Centricity PACS-IW-01273224, RU8953-Centricity PACS-IW-01273311, RU2367-Centricity PACS-IW-01273232, RU1026-Centricity PACS-IW-01273195, TBD-Centricity PACS-IW-01273198, RU8036-Centricity PACS-IW-01273293, RU7564-Centricity PACS-IW-01273286, RU3476-Centricity PACS-IW-01273251, RU3610-Centricity PACS-IW-01273257, RU1028-Centricity PACS-IW-01273197, RU1022-Centricity PACS-IW-01273194, RU5442-Centricity PACS-IW-01273277, RU3883-Centricity PACS-IW-01273267, RU3467-Centricity PACS-IW-01273250, RU3663-Centricity PACS-IW-01273259, RU7905-Centricity PACS-IW-01273291, TBD-Centricity PACS-IW-01273256, TBD-Centricity PACS-IW-01273296, RU7838-Centricity PACS-01273289, TBD-Centricity PACS-IW-01273218, RU8607-Centricity PACS-IW-01273308, ZA2470-Centricity PACS-IW-00116572, ZA2352-Centricity PACS-IW-00116570, ZA2471-Centricity PACS-IW-00116573, ZA2351-Centricity PACS-IW-00116569, ZA2356-Centricity PACS-IW-00116576, ZA2355-Centricity PACS-IW-00116575; g) 2052829-001, No UDI/DI, Product ID Numbers: 4300-1-Centricity PACS-IW-00558207; h) Not applicable, No UDI/DI, Product ID Numbers: N/A, Product ID Numbers: 2336375-Centricity PACS-IW-15773150

Product

Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g)…

Recalling firm

GE Healthcare

Quantity

153 units

Distribution

Worldwide Distribution

Recall date

May 10, 2023

Classification

Class II

Status

Ongoing

Agency

FDA (device)