Recall Z-2300-2016 ยท LLZ System, Image Processing, Radiological
Ge Healthcare It
Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data a
| Date | Feb 18, 2013 |
| Status | Terminated |
| Reason | A software defect was discovered that causes images to be out of context with clinical information. |
| Root cause | Software design |
| Action | GE sent an "Urgent Medical Device Correction" letter to all affected customers on April 2, 2013.The letter identified the product the problem and the action customers need to take. The software has been modified to correct these defects. The modified software will be released and installed in user sites through GE Healthcare FMI #85204. For further questions, please call ( 847) 277-4468. |
| Quantity | 13 |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052618 | IMAGECAST PACS Idx Systems Corp., Nov 17, 2005 |