Recall Z-2563-2011 ยท JQP Calculator/Data Processing Module, For Clinical Use
Ge Healthcare It
GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software; GE Healthcare IT Solutions, Barrington, IL 60010. The Centricity Laboratory is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with
| Date | Jun 14, 2011 (initiated May 3, 2011) |
| Status | Terminated |
| Reason | The GE Centricity Laboratory Instrument Interface to Data Innovations is processing a preliminary result instead of the final result from the Process System Manager when there is a test rerun conducted. |
| Root cause | Software design |
| Action | GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 3, 2011 to all affected customers. The letter describes the product, problem, and action to be taken by the customer. The letter provided the users with specific safety instructions to follow until the software was updated. The customers were requested to complete the enclosed customer reply form and fax the completed form to 847-620-2780. Any questions should be directed to their GE Service Representative or the GE Help desk at 888-778-3375. |
| Quantity | 14 units |
| Distribution | Worldwide Distribution-- USA (nationwide) including states of Georgia, New York, Ohio, Oregon, and Tennessee and countries of Canada, England, and Qatar. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.