Recall Z-1245-2011 ยท JQP Calculator/Data Processing Module, For Clinical Use
Ge Healthcare It
GE Centricity Laboratory software; GE Healthcare IT, Barrington, IL 60010. The intended use: the Centricity Laboratory is used 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. The Centricity Laboratory software is used to facilitate the general clinica
| Date | Feb 15, 2011 (initiated Dec 3, 2010) |
| Status | Terminated |
| Reason | The GE Centricity Laboratory System Software has safety issues with the "Telephone List" function, the "Anatomic Pathology" application, and the Instrument Interface IO module that may impact patient safety. |
| Root cause | Software design |
| Action | GE Healthcare, sent "Urgent Medical Device Correction" letters dated December 12, 2010 to GE Centricity Laboratory software customers on the same date. The letters advised the users of the product, the problem, and the action to be taken by the customer. The letters 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 | 26 units |
| Distribution | Worldwide Distribution -- USA, including AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MI, MN, MO, NC, NH, NJ, NY, OR, TN, VA, and WI, , and internationally to the countries of Australia, England, Hong Kong, India, Malaysia, New Zealand, Qatar, Scotland and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.