GE Healthcare GmbH: GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

Hazard

GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.

Details from the source

Reason for recall: GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information. Distribution: Worldwide Quantity: 1221 units Lot/code info: ViewPoint 6 version 6.15.3, UDI (01)00195278753472(10)ViewPoint6.15.3.0, System ID numbers: F0HD Y23W, TR41 MQHH, MMZR D4YS, YJJM BH20, 02GQ KX8N, Y13Z CK8A, 215K QT2P, R2RQ 6S9K, 3SD3 XRBX, 64TY MCQ5, SU3C 35BJ, FURE QR5U, 493M 8J65, E206 FXM2, 0QN8 K9Z5, 2PM0 2G22, Y3EK ZG4H, XM7F JE94, T-XQH5 RGGW, JXAK BGRN, X563 55KC, Q759 NQ3T, YUC5 E1B7, M4DN P5QT, HJU6 59Y2, PXDU YRPA, XDRU PP57, GA26 M2DT, 7QZY K6XB, FH9H X5S1, HH3Y Y4W3, R4JZ 668A, 8E00 EY8A, BSB4 FJDK, T-BSB4 FJDK, CR6U 0AQ1, 20XB 0UAS, SKSK 3JNJ, KUT3 2W8P, 7H6Q RE0Z, 5KDZ 640J, 1M4R 8H6R, T-KN5N NE40, KN5N NE40, 576N X8R0, B8R9 HHAP, NFG0 C3GZ, R546 M5JW, T-R546 M5JW, 959J 7955, CCZ5 BXGJ, AXDF 5QS9, 73C8 M5NZ, GZZ6 R27Y, PT24 XDAM, EMUP X20W, 1J2C FXHS, T-1J2C FXHS, 3DUC WYDK, TG21 RSW3, 6XUS 9XCZ, M4CF 0WQ5, ERYR WQER, HKWC SUYQ, AC6A YG37, GC11 B3UG, UMXB HG5Z, T-B26E J931, 947H U85K, Q7PY 5WN5, PSUP PUC9, BEFY R4UN, 43MK TD9D, RS9S A4R2, U6BE 5BX6, 59EZ 9872, C9UY 3KDK, F9B2 8MRB, Z7X5 H282, X5G6 76RS, M32Q Z36T, A65S 86WP, CMNA RFPH, T-KA2Y 4HY3, T-YA80 ZX5C, T-8FFF PD4M, T-36Z7 UAS5, WYQ8 PCK1, T-Y9EP 31QZ, 4F2C Y3PQ, T-F8NN MB9J, HH64 GRKC, 0UWX FH6R, RJPJ R5R6, UWWH ZMHN, XXY0 AR3T, ME61 Z278, 49RT 5QXB, F6B9 CS51, 42WG 8946, CZSC DJ7B, E53Q DS7F, 1JU9 764P, 0G4S UA94, EN2K 6QM6, YDDG 0HJ1, QTR8 1F3J, 59D5 WJAS, W15C GMAH, HDAX CJKK, SZ8Z W9CZ, QNTU 134G, 8QKN 3HQ4, HMZC M3EK, PJGR 9JDD, 28NM WM72, 0HFE QU9U, 511S JXX6, TAM7 HWSE, 1T2S ZW22, PF3Z RMAG, G3NQ TWAP, JN9B 6APN, 2MDC 9MWA, 1Y1G 94YN, 4XZZ KC8B

UPC codes

00195278753472

Source

Official record: FDA (Device enforcement) ↗

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