Recall Z-1093-2012 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Healthcare, LLC
GE Healthcare, LOGIQ S8 DIAGNOSTIC ULTRASOUND SYSTEM with R1.1.0 Software. Intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ; Peripheral Vascular, etc.
| Date | Feb 23, 2012 (initiated Feb 7, 2012) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential safety issue where an image from a different patient, or an image from the current patient with title information from a different patient maybe noticed. |
| Root cause | Software design |
| Action | Consignees were sent on 2/7/12 a GE Healthcare "Urgent Medical Device Correction" letter dated February 6, 2012. The letter was addressed to Hospital Administrators / Risk Manager, Biomedical Engineering and Head of General Imagining Ultrasound Department. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Users were instructed not to press the PRINT key during the specified view in order to avoid seeing the issue. GE will provide a software update at not cost to customers in order to remove the malfunction. C |
| Quantity | 161 |
| Distribution | Worldwide Distribution -- US, including the states of NJ, PA, and WI and countries of UNITED KINGDOM, THAILAND, SOUTH KOREA, SLOVENIA, SINGAPORE, ROMANIA, REPUBLIC OF MOLDOVA, POLAND, MALAYSIA, JAPAN, ITALY, INDIA, GERMANY, FRANCE, EUROPE, CZECH REPUBLIC, AUSTRIA, AUSTRALIA, and ARAB EMIRATES. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111582 | LOGIQ S8 GE Healthcare, Jul 26, 2011 |