FDAFDA · Food and drugs·Recall number Z-3146-2024
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
Published September 25, 2024 · Recall initiated: August 8, 2024
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
The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare GmbH
- Distributor
- US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
- Lot
- a) H47581RJ: UDI/DI none, System ID Numbers: 4AD8 4XH3, JC82 KQTA, JZNQ HCW6, 8X0C HWWG, NURM T75T, 7R98 NQWY, AS41 ZJKE, ZU21 YYU8, E09H GGMN, DZMC NUA6, CYPQ ARE7, HJDP BKTB, TMQA Y5KK; b) H47591MA: UDI/DI (01)00840682103640(10)SP1, System ID Numbers: ND1G 9XAQ, Q6BJ 97G9, N8XB JU3W, UD55 W4Y3, KN5N NE40, TPF5 XNX3, 3WUB CTJ7, 113A SQPB, ZPFQ PU2B, MCH1 D8NX, Y9EP 31QZ, and UDI/DI (01)00840682103640(10)SP2, System ID Numbers: 20GN P6K5, NZHH 8S6X, F7RD DEWF, BJ4S RHT3, M6CS 194S, 0EKT TEUF, 4M7U QK91, RH1J 5CQ4; c) H47591MT: UDI/DI (01)00840682119627(10)ViewPoint6ver6.8SP1, System ID Numbers: A9PQ QW8P, HQDC YM8P, QQA4 5NMB, BGWN FEDE, QWMX 3H8H, BWXS F2FH, CZE2 JKSD, BB1Z NZ0R, N5MC 865W, ZUUT 01QZ, 6XX2 SW1N, 4F2C Y3PQ; d) H47591PE: UDI/DI (01)00840682124454(10)ViewPoint6ver6.9SP1, System ID Numbers: G00B ZJM0, 3EU2 009D, 0XP7 EJ8B, 2RUA PEXN, XNG8 X0DD, T0B8 YRFY, WGC2 8WNW, XTZN HZZZ, RJ0X 800T, BEJF WA1P, ZWM3 FRS9, 2WS7 2E10, 36SG U594, H1KX 82WQ, B8RY Z8EX, 7H6Q RE0Z, 83DP SKEE, SXD5 AGT3, ZZ68 YF5D, 6P8Z HH0D, AWM3 2FUB, ANMQ BM23, QN6D Z8PY, Q402 P0GK, WWN2 2HEU, 27F2 BP46, U3XC HZD9, FQWU 93WN, JFAH SDP2, MFUY 4K1Q, AG8N 1M16, HHGB AX1S, 1945 W95R, FC98 GMZK, MYSU ANGZ, 349X NMBE, QC0C 68Y8, E67Q QR0T, CPFN 64AA, H74D 565Z, H6SA 05SZ, KZWJ XZZ4, HH72 G643, EMHH R4B4; e) H47591PR: UDI/DI (01)00840682140744(10)ViewPoint6ver6.10SP1, System ID Numbers: AQ7G R7RP, 819A DHUF, CB3X ZXZZ, Q2GT YFTG, 947H U85K, Z7X5 H282, 5DQN S2Y0, and UDI/DI (01)00840682140744(10)ViewPoint6ver6.10SP2, System ID Numbers: TPW0 WRFA, MSXR PRQD, T2RH C58F, RGKE SE9U, 6SYX CC6K, 6MB1 4CB4, M24A 7EWH, R953 RT7G, TR41 MQHH, 02GQ KX8N, MMZR D4YS, 2UXP F2A3, 709N QMAF, SU3C 35BJ, Q9FW 4TA6, 5TE3 Y7FY, 64TY MCQ5, H3RR 9HGE, 2PM0 2G22, YJJM BH20, 493M 8J65, WF9Z SSBJ, ACP6 E9U6, XXJN UCT2, B80C XNJ7, E8E2 KA1N, Y13Z CK8A, MKY3 D2DD, 3SD3 XRBX, XX4F HS65, 2HD6 1CNZ, F4HW 726E, RDDG X11H, NX5D 2ZPA, 73GK 1DD5, JQFG 6F35, NFG0 C3GZ, FM1Z WP6J, 6832 2N28, 8C7S 4639, R269 1JA3, SUWT E2CR, E206 FXM2, 3CDT 9NA6, PRTM K1AG, KAZS CJJX, QCUZ P4ZE, AG4P H5ER, ZHU7 2YRB, AAP4 9R1S, TCNU MJ80, JAPJ UYWP, NDMG F4KT, AH0Q QFM6, 15B4 DFZT, D2AF H6XM, ZN9A BKX0, X3PN G18S, H3C5 F38G, DFW6 NDQJ, TQ6W CGT8, PAD6 Q1PQ, YA80 ZX5C, FURE QR5U, AC6G PQ4B, KQZW Q6SE, Z3ZS RGTF, QWRD 7NAB; f) H47591RA: UDI/DI (01)00840682145718(10)ViewPoint6ver6.11SP0, System ID Number KZPS FRWY, UDI/DI (01)00840682145718(10)ViewPoint6ver6.11SP1, System ID Numbers: ND5D 7HZC, and UDI/DI (01)00840682145718(10)ViewPoint6ver6.11SP2, System ID Numbers: XJGZ 387F, WXQC 2A6C, F0HD Y23W, 3HMS XSS7, GASK Z7NC, Z5TQ W473, 2K3Y 6EE9, 1E8F MAMA, AQZN 1XRF, 5WQZ 3W8Y, 2P5F 7J1F, CHX3 3297, H47Z N0B5, B07D 2ME7, GZMT BYH8, KPW3 F1NE, AR99 WFJ9, BDSN YWMF, TT6J SFRP, 03HQ 0PC4, R4K0 9X4N, 476N EKFA, 8E00 EY8A, U7ZN 0Q09, TABD H8Y2, TMA8 HPS1, 8824 K165, SKSK 3JNJ, KUT3 2W8P, SKDB B40U, 1M4R 8H6R, B9KW WRBU, 055X UZ0D, F8GR MTPQ, 3ZZR E77H, AXDF 5QS9, X1G8 5TC1, ET61 W09J, TYN4 CNSR, HU2F DJRQ, 3X5B 37QX, GZZ6 R27Y, XESN Z4AB, B12P C0KD, Z3BW FD43, Z3EW WND9, A6G8 8MMF, GQSD 4NH8, 0P6W ZDG9, WTTE BYF2, 263Z NKFF, ZT4Y 8B0R, ZX0E SSG4, 1B10 JD5C, XHB7 X3B1, CJWA 3QG5, CYUZ GBTG, H406 4J0E, G4NJ FMCX, XSF7 9X5W, GKUR ZK31, SFRE GHM0, Q8XC SRQD, BHZU T59K, 1PBG C7SW, TXWF NHB7, G762 X178, R2BF 9SJK, AC6A YG37, DXU9 6URP, JK3Q BCTP, D5QB Y5TB, TSX0 P5G5, 5QGG 8KPS, HDSF ER48, BP30 7JMH, XQH5 RGGW, MWWJ CM5X, Q7PY 5WN5, RSZQ QERS, DNEP 05SZ, NZD8 3YA6, R1H6 YBER, 3MJC 527M, XXZR CH7A, MEN8 SNBU, JJ7C 0E01, 1A2G DDUF, NTHM Q2GT, 59EZ 9872, Y223 6XTN, 7QJZ EQPB, 8CY4 4FW8, X5G6 76RS, CMNA RFPH, 24S0 QJZZ, TDZG HXDC, KA2Y 4HY3, FWHX 8X72, YA3F CH7S, 1E8C 2XY3, C42Y HNJZ, S9XQ 87U2, 0A4U ZSRS, AKYW AFYB, 1N09 M1BW, 6FH7 JH2M, HH64 GRKC, 0UWX FH6R, UZGJ 440R; g) H47591SD: UDI/DI (01)00840682171953(10)ViewPoint6ver6.12SP0, System ID Numbers: 79CP 1RUY, 89NZ 31BX, UDI/DI (01)00840682171953(10)ViewPoint6ver6.12SP1(11)210400, System ID Numbers: DKKD US12, X00G 3W54, 54ZD SW0U, 0XR7 QBG7, KJC2 X4T
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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