Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling certain Vivid E95, E90, and E80 ultrasound systems due to an issue where the wrong patient can be incorrectly selected by the operator when DICOM Worklist search response times are slow. When this occurs, incorrect patient information may display on the screen during an exam, and if the operator does not catch the error, the ultrasound images from the intended patient will be stored under the wrong patient's name. This could result in misdiagnosis. No injuries have been reported to date.
The recall affects 971 systems (412 in the US and 559 outside the US) distributed across numerous countries. Affected consumers should check whether their system's serial number is listed among the recalled units. The recall record does not specify what remedy or corrective action GE Healthcare is providing.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: United Kingdom, United Arab Emirates, Turkey, Thailand, Switzerland, Sweden, Spain, South Africa, Slovenia, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Norway, New Zealand, New Caledonia, Netherlands, Myanmar, Kuwait, Korea (Republic of), Japan, Italy, ISRAEL, Ireland, Iran, India, Hungary, Hong Kong, Guatemala, Greece, Great Britain, Germany, France, Finland, Estonia, Egypt, Ecu Quantity: 971(412 US; 559 OUS) Lot/code info: 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 VE95000281 AU00287 VE95000287 AU00300 VE95000300 AU00302 VE95R000302 AU00321 VE9500321 AU00329 VE95000329 AU00330 VE95000330 AU00331 VE9500331 AU00332 VE95000332 AU00335 VE95R000335 AU00339 VE9500339 AU00347 VE95000347 AU00348 VE95000348 AU00352 VE95000352 AU00359 VE9500359 AU00360 VE95000360 AU00361 VE95000361 AU00363 VE95000363 AU00367 VE95000367 AU00368 VE95000368 AU00369 VE95000369 AU00370 VE95000370 AU00372 VE95000372 AU00373 VE95000373 AU00374 VE9500374 AU00376 VE95R00376 AU00388 VE95000388 AU00396 VE95000396 AU00398 VE95000398 AU00401 VE9500040
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.