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
FDA device recall Z-1096-2013 · posted 2013-04-11 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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
- Action taken
- Consignees were sent on 2/8/2013 a GE Healthcare " Urgent Medical Device Correction" letter dated February 8, 2013. The letter was addressed to Hospital Administrators / Risk Manager, Biomedical Engineering and Managers of General/Diagnostic Imaging. The letter described the Safety Issue, Safety Instructions, Affected Product details, Product correction and Contact Information. US customer contact number is (1)800-437-1171.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 2061
- Distribution
- Worldwide Distribution, USA, including the states of AL, AZ, AR, CA, CO,K CT, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT NE, NV N NJ, NM, NY, NC, ND, OH, OK, PA, RI ,SC, SD, TN, TX
- Date initiated
- 2013-02-08
- Date posted
- 2013-04-11
- Date terminated
- 2013-11-21
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LOGIQ S7 EXPERT, LOGIQ S7 PRO (K122114) | GE Healthcare | 2012-10-03 |
| LOGIQ S8 (K111582) | GE Healthcare | 2011-07-26 |