FDA Device recall Z-1780-2017

Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD

FDA Device
Class II
terminated
Published 2017-04-19

On 2017-04-19 the FDA classified a Class II recall of Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD by Ge Healthcare, citing GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1780-2017
Classification	Class II
Status	terminated
Initiated	2017-03-10
Published	2017-04-19
Last updated	2026-09-13 11:54 UTC
Company	Ge Healthcare
Distribution	n/a

Product

Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.

Reason

GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. If not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. This issue could lead to misdiagnosis. There have been no injuries reported because of this issue.

Identifiers

code_info	Mfg. Lot or Serial # System ID 000955S60 VS60000955 000973S70 VS70000973 000974S70 VS7000974 000997S70 VS70000997… Mfg. Lot or Serial # System ID 000955S60 VS60000955 000973S70 VS70000973 000974S70 VS7000974 000997S70 VS70000997 001022S70 VS70001022 001020S70 VS70001020 000941S70 VS70000941 000951S70 VS70000951 000982S70 VS70000982 000981S70 VS70000981 000994S70 VS70000994 000976S70 VS70R000976 000993S70 VS70000993 000980S70 VS70000980 000998S70 VS70R000998 000996S70 VS70000996 001005S70 VS70001005 001010S70 VS70001010 001007S70 VS70001007 001008S70 VS70001008 001021S70 VS70001021 001029S70 VS70001029 001040S60 VS60001040 001052S70 VS70001052 001048S70 VS70001048 001051S70 VS70001051 001066S60 VS60001066 001054S60 VS60001054 001059S70 VS70001059 001064S70 VS70001064 001067S70 VS70001067 001062S70 VS70001062 001047S70 VS70001047 001050S70 VS70001050 001073S70 VS70001073 001076S70 VS70001076 001078S70 VS70001078 001074S70 VS70001074 001129S70 VS70001129 001120S60 VS6001120 001137S70 VS70001137 001157S70 VS70001157 001230S60 VS60001230 001246S60 VS60001246

code_info

Mfg. Lot or Serial # System ID 000955S60 VS60000955 000973S70 VS70000973 000974S70 VS7000974 000997S70 VS70000997…

Mfg. Lot or Serial # System ID 000955S60 VS60000955 000973S70 VS70000973 000974S70 VS7000974 000997S70 VS70000997 001022S70 VS70001022 001020S70 VS70001020 000941S70 VS70000941 000951S70 VS70000951 000982S70 VS70000982 000981S70 VS70000981 000994S70 VS70000994 000976S70 VS70R000976 000993S70 VS70000993 000980S70 VS70000980 000998S70 VS70R000998 000996S70 VS70000996 001005S70 VS70001005 001010S70 VS70001010 001007S70 VS70001007 001008S70 VS70001008 001021S70 VS70001021 001029S70 VS70001029 001040S60 VS60001040 001052S70 VS70001052 001048S70 VS70001048 001051S70 VS70001051 001066S60 VS60001066 001054S60 VS60001054 001059S70 VS70001059 001064S70 VS70001064 001067S70 VS70001067 001062S70 VS70001062 001047S70 VS70001047 001050S70 VS70001050 001073S70 VS70001073 001076S70 VS70001076 001078S70 VS70001078 001074S70 VS70001074 001129S70 VS70001129 001120S60 VS6001120 001137S70 VS70001137 001157S70 VS70001157 001230S60 VS60001230 001246S60 VS60001246

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1780-2017%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.