Recall Z-0865-2014 ยท JQP Calculator/Data Processing Module, For Clinical Use
GE Healthcare It
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mai
| Date | Jan 29, 2014 (initiated Nov 20, 2012) |
| Status | Terminated |
| Reason | GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Laboratory Core Lab calculated results in two scenarios. In Scenario 1: Calculated results greater than 6 digits plus a decimal are reported as 0 instead of TOO BIG when significant figures are not defined for the item. In Scenario 2: Calculated results greater than 6 digits plus a decimal are trunc |
| Root cause | Software design |
| Action | An URGENT MEDICAL DEVICE CORRECTION letter date March 12, 2013 was sent to customers. The letter requests that customers review all calculated results to determine if either of the scenarios could occur at their site. If a customer determines that either of the scenarios proposed in the letter could occur at their site, the customer can contact their GE service representative to request or install the software update. Customers with questions can contact the GE Healthcare IT Helpdesk at 1-847-589-8496 or tgg.nahelpdesk@med.ge.com. |
| Quantity | 7 units |
| Distribution | Worldwide Distribution - US (Nationwide) to states of: MN, GA, and CA; and International to: England. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.