FDA Device recall Z-1096-2013
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) diagnos…
- FDA Device
- Class II
- terminated
- Published 2013-04-17
On 2013-04-17 the FDA classified a Class II recall of 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) diagnos… by Ge Healthcare, citing 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 d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1096-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-08 |
| Published | 2013-04-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | 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 |
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
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
Identifiers
| code_info | Mfg Lot or Serial # 176132SU9 176138SU6 178028SU7 158247SU7 172656SU1 187599SU6 201614SU5 201615SU2 195234SU0…Mfg Lot or Serial # 176132SU9 176138SU6 178028SU7 158247SU7 172656SU1 187599SU6 201614SU5 201615SU2 195234SU0 195237SU3 161686SU1 203123SU5 170272SU9 189160SU5 189162SU1 170273SU7 185619SU4 176924SU9 191894SU5 159964SU6 159768SU1 170197SU8 158248SU5 171540SU8 171541SU6 160741SU5 160742SU3 160743SU1 159766SU5 197761SU0 198949SU0 195241SU5 189928SU5 164268SU5 159963SU8 185116SU1 195242SU3 201967SU7 166218SU8 185968SU5 189165SU4 189166SU2 189167SU0 189168SU8 189169SU6 195235SU7 195236SU5 171371SU8 168779SU7 189163SU9 190393SU9 159767SU3 167274SU0 201464SU5 195233SU2 171369SU2 177085SU8 186501SU3 171370SU0 187022SU9 191063SU7 185969SU3 168788SU8 159965SU3 201612SU9 159604SU8 178592SU2 178593SU0 178594SU8 178595SU5 185620SU2 185621SU0 176926SU4 176925SU6 191893SU7 177084SU1 192952SU0 195238SU1 195239SU9 195240SU7 201971SU9 201972SU7 202046SU9 195881SU8 186579SU9 204275SU2 171542SU4 171947SU5 192951SU2 |
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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-1096-2013%22
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