FDA Device recall Z-1944-2013
GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal
- FDA Device
- Class II
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class II recall of GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal by Ge Healthcare, citing GE Healthcare became aware of a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. This issue was found internally. Users….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1944-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-13 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Reason
GE Healthcare became aware of a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. This issue was found internally. Users may notice that the system shows incorrect image measurement results on Pulsed Wave (PW) or Time Intensity Curve (TIC) or depth measurement when using Virtual Convex mode and putting a cursor (Sample Volume, Depth measur
Identifiers
| code_info | Mfg Lot or Serial # 171947SU5 176566SU8 176567SU6 179458SU5 182385SU5 182653SU6 182654SU4 182656SU9 164236SU2…Mfg Lot or Serial # 171947SU5 176566SU8 176567SU6 179458SU5 182385SU5 182653SU6 182654SU4 182656SU9 164236SU2 173818SU6 172242SU0 172243SU8 176260SU8 180632SU2 181231SU2 181232SU0 181233SU8 181234SU6 181235SU3 158763SU3 158799SU7 159780SU6 163222SU3 165600SU8 168075SU0 169495SU9 170681SU1 170893SU2 171937SU6 171941SU8 171943SU4 176123SU8 176125SU3 176129SU5 177080SU9 178951SU0 180108SU3 180110SU9 180763SU5 180766SU8 182661SU9 182379SU8 176132SU9 159604SU8 159766SU5 158247SU7 172656SU1 161686SU1 170273SU7 170272SU9 170274SU5 176924SU9 159768SU1 170197SU8 171541SU6 171540SU8 171542SU4 164268SU5 166218SU8 171371SU8 168779SU7 167274SU0 171369SU2 177085SU8 177084SU1 171370SU0 168788SU8 178593SU0 178594SU8 178595SU5 176926SU4 176925SU6 158248SU5 159963SU8 160741SU5 160742SU3 160743SU1 159964SU6 178592SU2 159965SU3 159767SU3 181434SU2 166181SU8 183107SU2 169509SU7 159792SU1 183118SU9 170672SU0 176130SU3 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1944-2013%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.