Reported May 10, 2023 · Ongoing
Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012,…
GE Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare · 500 W Monroe St · Chicago, IL · 60661-3671
Is this the product you have?
- Centricity PACS-IW
- Product ID Numbers
a) 2041037-001b) 2042988-001c) 2049587-009d) 2049587-011e) 2049587-012f) 2049587-015g) 2052829-001h) Not applicableRadiological Image Processing System
- Lot codes and dates
- a) 2041037-001, No UDI/DI
- Product ID Numbers
4443-1-Centricity PACS-IW-00558167b) 2042988-001No UDI/DI
- Product ID Numbers
707509-Centricity PACS-IW-01452391613493-Centricity PACS-IW-02292544SiteID-Centricity PACS-IW-01572187c) 2049587-009No UDI/DI
- Product ID Numbers1402-7-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-005583124352-1-Centricity PACS-IW-00558316PL1825-Centricity PACS-IW-0003881914335625-Centricity PACS-IW-20614918e) 2049587-012No UDI/DI
- Product ID Numbers
100858-1-Centricity PACS-IW-005584264109-1-Centricity PACS-IW-005583894294-1-Centricity PACS-IW-0055837913039-1-Centricity PACS-IW-00558385101742-1-Centricity PACS-IW-005584709791-1-Centricity PACS-IW-0055841811764-1-Centricity PACS-IW-00558388101689-1-Centricity PACS-IW-005583264744-1-Centricity PACS-IW-005583734374-1-Centricity PACS-IW-005584224277-1-Centricity PACS-IW-00558474101216-1-Centricity PACS-IW-00558356101240-1-Centricity PACS-IW-005584254361-1-Centricity PACS-IW-0055834312949-1-Centricity PACS-IW-005584424393-1-Centricity PACS-IW-00558328100645-1-Centricity PACS-IW-147644514573-1-Centricity PACS-IW-005584204506-1-Centricity PACS-IW-00558345AZ4030-Centricity PACS-IW-02336621324462-Centricity PACS-IW-01431554246838-Centricity PACS-IW-01421153280801-Centricity PACS-IW-01431490307319-Centricity PACS-IW-01444609StThomas-Centricity PACS-IW-01819447WOCKHARDT-Centricity PACS-IW-01819449SIMS-Centricity PACS-IW-01819453MARTHANDAM-Centricity PACS-IW-01819446CONTINENTAL-Centricity PACS-IW-01819443KW1112-Centricity PACS-IW-00168151BEVERLY-Centricity PACS-IW-01288659MAHKOTA-Centricity PACS-IW-01286179UMUM-Centricity PACS-IW-01288666RU2580-Centricity PACS-IW-01273240ONCOLOGY-Centricity PACS-IW-01288658f) 2049587-015No UDI/DI
- Product ID Numbers
91 of 91 codes
4345-1-Centricity PACS-IW-00558548101792-1-Centricity PACS-IW-005583704378-1-Centricity PACS-IW-00558498100663-1-Centricity PACS-IW-00558514100702-1-Centricity PACS-IW-00558539101625-1-Centricity PACS-IW-005585314593-1-Centricity PACS-IW-00558488100009-1-Centricity PACS-IW-00558560100838-1-Centricity PACS-IW-0055853213102-1-Centricity PACS-IW-005585124694-1-Centricity PACS-IW-00558556101883-1-Centricity PACS-IW-005584874358-1-Centricity PACS-IW-0055856413095-1-Centricity PACS-IW-005585344326-4-Centricity PACS-IW-005581054301-1-Centricity PACS-IW-005585252387-1-Centricity PACS-IW-00558489100802-1-Centricity PACS-IW-00558540101193-1-Centricity PACS-IW-005585514661-1-Centricity PACS-IW-005585283943-1-Centricity PACS-IW-005585014383-1-Centricity PACS-IW-0055853313233-3-Centricity PACS-IW-005585544389-1-Centricity PACS-IW-00558563302144-Centricity PACS-IW-01421157213537-Centricity PACS-IW-01431510319674-Centricity PACS-IW-01431535RMUE01-Centricity PACS-IW-00001801A2513980-Centricity PACS-IW-00040355KW1019-Centricity PACS-IW-00115173KW1018-Centricity PACS-IW-01422962KW1003-Centricity PACS-IW-01798078KW1001-Centricity PACS-IW-00164288SSH-Centricity PACS-IW-01288660PL2997-Centricity PACS-IW-00038793PL1803-Centricity PACS-IW-00038812PL1006-Centricity PACS-IW-00038821PL1822-Centricity PACS-IW-00038825TBD-Centricity PACS-IW-01273193RU1241-Centricity PACS-IW-01273216RU1493-Centricity PACS-IW-01273220TBD-Centricity PACS-IW-01273244RU2420-Centricity PACS-IW-01273234RU3262-Centricity PACS-IW-01273245RU6248-Centricity PACS-IW-01273279RU8052-Centricity PACS-IW-02337508RU8071-Centricity PACS-IW-01273295-Centricity PACS-IW-01273233RU7576-Centricity PACS-IW-01273287RU3880-Centricity PACS-IW-01273266RU2527-Centricity PACS-IW-01273235RU2878-Centricity PACS-IW-01273243TBD-Centricity PACS-IW-01273306TBD-Centricity PACS-IW-01273258RU5499-Centricity PACS-IW-01273278RU1279-Centricity PACS-IW-02337628RU1469-Centricity PACS-IW-01273219TBD-Centricity PACS-IW-01273200RU8321-Centricity PACS-IW-01273303RU1130-Centricity PACS-IW-01273210
- Product ID Numbers4300-1-Centricity PACS-IW-00558207; h) Not applicable, No UDI/DI
- Product ID NumbersN/A
- Product ID Numbers2336375-Centricity PACS-IW-15773150
- Amount recalled
- 153 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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