FDA Device recall Z-0935-2026

GE HealthCare ViewPoint 6, Catalog Number H47601AA

FDA Device
Class II
ongoing
Published 2025-12-24

On 2025-12-24 the FDA classified a Class II recall of GE HealthCare ViewPoint 6, Catalog Number H47601AA by Ge Healthcare, citing 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 informat….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0935-2026
Classification	Class II
Status	ongoing
Initiated	2025-11-03
Published	2025-12-24
Last updated	2026-09-13 11:57 UTC
Company	Ge Healthcare
Distribution	n/a

Product

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

Reason

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.

Identifiers

code_info	ViewPoint 6 version 6.15.3, UDI (01)00195278753472(10)ViewPoint6.15.3.0, System ID numbers: F0HD Y23W, TR41 MQHH, MMZR… 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

code_info

ViewPoint 6 version 6.15.3, UDI (01)00195278753472(10)ViewPoint6.15.3.0, System ID numbers: F0HD Y23W, TR41 MQHH, MMZR…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0935-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.