FDA Device recall Z-1779-2017

Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA

FDA Device
Class II
terminated
Published 2017-04-19

On 2017-04-19 the FDA classified a Class II recall of Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA 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-1779-2017
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 E95/E90/E80, H45581DC, H45581LB and H45581DA.

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 1 VE95R00100 AU00104 VE95R00104 AU00107 VE95R00107 AU00109 VE95R000109 AU00110 VE95… Mfg. Lot or Serial # System ID 1 VE95R00100 AU00104 VE95R00104 AU00107 VE95R00107 AU00109 VE95R000109 AU00110 VE95R000110 AU00111 VE95R000111 AU00113 VE95R000113 AU00117 VE95R000117 AU00118 VE95R000118 AU00120 VE95000120 AU00121 VE95R000121 AU00123 VE95R000123 AU00124 VE95R000124 AU00125 VE95R000125 AU00126 VE90000126 AU00127 VE95R000127 AU00128 VE95R000128 AU00132 VE90000132 AU00133 VE95R000133 AU00135 VE90000135 AU00138 VE95R000138 AU00159 VE95R000159 AU00160 VE9500160 AU00162 VE95000162 AU00165 VE95000165 AU00168 VE95000168 AU00171 VE90000171 AU00172 VE95R000172 AU00173 VE90000173 AU00174 VE90000174 AU00176 VE95000176 AU00182 VE95000182 AU00183 VE90000183 AU00184 VE95R000184 AU00206 VE9500206 AU00207 VE95U00207 AU00211 VE9500211 AU00224 VE90000224 AU00230 VE95000230 AU00231 VE90000231 AU00232 VE90000232 AU00240 VE95R000240 AU00242 VE95000242 AU00243 VE90000243 AU00246 VE95V000246 AU00258 VE90000258 AU00277 VE95R000277 AU00281 VE9500028

code_info

Mfg. Lot or Serial # System ID 1 VE95R00100 AU00104 VE95R00104 AU00107 VE95R00107 AU00109 VE95R000109 AU00110 VE95…

Mfg. Lot or Serial # System ID 1 VE95R00100 AU00104 VE95R00104 AU00107 VE95R00107 AU00109 VE95R000109 AU00110 VE95R000110 AU00111 VE95R000111 AU00113 VE95R000113 AU00117 VE95R000117 AU00118 VE95R000118 AU00120 VE95000120 AU00121 VE95R000121 AU00123 VE95R000123 AU00124 VE95R000124 AU00125 VE95R000125 AU00126 VE90000126 AU00127 VE95R000127 AU00128 VE95R000128 AU00132 VE90000132 AU00133 VE95R000133 AU00135 VE90000135 AU00138 VE95R000138 AU00159 VE95R000159 AU00160 VE9500160 AU00162 VE95000162 AU00165 VE95000165 AU00168 VE95000168 AU00171 VE90000171 AU00172 VE95R000172 AU00173 VE90000173 AU00174 VE90000174 AU00176 VE95000176 AU00182 VE95000182 AU00183 VE90000183 AU00184 VE95R000184 AU00206 VE9500206 AU00207 VE95U00207 AU00211 VE9500211 AU00224 VE90000224 AU00230 VE95000230 AU00231 VE90000231 AU00232 VE90000232 AU00240 VE95R000240 AU00242 VE95000242 AU00243 VE90000243 AU00246 VE95V000246 AU00258 VE90000258 AU00277 VE95R000277 AU00281 VE9500028

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-1779-2017%22

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