GE Healthcare LOGIQ S8 — Class II medical device recall Z-1096-2013
Terminated recall by GE Healthcare, LLC, reported 2013-04-17, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunc
| Recall number | Z-1096-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-02-08 |
| Classified | 2013-04-11 |
| Reported by FDA | 2013-04-17 |
| Terminated | 2013-11-21 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA, WI |
| Countries outside the US | AE, AT, AU, BR, CH, CL, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, HU, ID, IN, IT, JP, KR, LB, LV, MA, MX, MY, NL, NO, NZ, PH, PL, PT, RO, RU, SA, SE, SG, SI, TH, TN, TR, TW, VN, ZA |
| Quantity | 2,061 |
| Serial numbers | 153251SU4, 153252SU2, 153253SU0, 153254SU8, 153255SU5, 153256SU3, 153257SU1, 153258SU9, 153259SU7, 153260SU5, 158235SU2, 158236SU0, 158237SU8, 158238SU6, 158239SU4, 158240SU2, 158241SU0, 158242SU8, 158243SU6, 158244SU4, 158245SU1, 158246SU9, 158247SU7, 158248SU5, 158259SU2 and 475 more |
Product
GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation.
Reason for recall
GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered that this issue also leads to a specification issue of the acoustic output of this probe. There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultraso
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-1096-2013. 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.