Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled certain Vivid S60/S70/S60N/S70N ultrasound systems because of a software issue that can cause an operator to incorrectly select the wrong patient when the DICOM Worklist search response time is slow. When this occurs, incorrect patient information may display on the screen during the exam, and if the operator does not catch the error, ultrasound images from the intended patient will be stored under the wrong patient's records. This could potentially lead to misdiagnosis. No injuries have been reported from this issue.
The recall affects 396 systems total (67 in the US and 329 outside the US) distributed across numerous countries including the United Kingdom, Japan, Germany, France, India, and others. The source document does not specify what action affected consumers should take in response to this recall.
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: 396 (67 US; 329 OUS) Lot/code info: 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 001253S60 VS6001253 001336S60 VS6001336 001345S60 VS60001345 000948S70 VS70000948 000995S70 VS70000995 001053S70 VS70001053 001055S60 VS60001055 001056S70 VS70001056 001039S70 VS70001039 001060S70 VS70001060 001069S70 VS70001069 001112S60 VS60001112 001128S70 VS70001128 001138S70 VS70001138 001163S70 VS70001163 001165S70 VS70001165 001238S60 Not Available 001256S60 VS60001256 001003S70 VS70001003 001332S60 VS60001332 001347S60 VS60001347 001329S60 VS60001329 001310S60 Not Available 001250S70 Not Available 000969S70 VS70969S70 000971S70 001
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.