GE Healthcare — Class II medical device recall Z-1944-2013
Terminated recall by GE Healthcare, LLC, reported 2013-08-21, distributed nationwide. GE Healthcare became aware of a potential issue related to incorrect image measurement associated with the sof
| Recall number | Z-1944-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-08-13 |
| Classified | 2013-08-09 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2014-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BR, CA, CH, CO, CZ, DE, DK, DZ, EE, ES, FI, FR, GB, GR, ID, IE, IN, IT, JP, KR, LB, LV, MA, MY, NL, NO, NZ, PL, PT, RO, SA, SE, SG, SI, TH, TN, TR, ZA |
| Quantity | 755 |
| Reason classes | software |
| Serial numbers | 153254SU8, 153255SU5, 153256SU3, 153257SU1, 153258SU9, 153259SU7, 153260SU5, 158235SU2, 158236SU0, 158237SU8, 158238SU6, 158239SU4, 158240SU2, 158241SU0, 158242SU8, 158243SU6, 158244SU4, 158245SU1, 158246SU9, 158247SU7, 158248SU5, 158259SU2, 158759SU1, 158760SU9, 158761SU7 and 475 more |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1944-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.