Recall Z-0182-2012 ยท LLZ System, Image Processing, Radiological
Philips Medical Systems
Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period A nuclear medicine image display and processing application suite that provided software applications used to process analyze and display medical images/data.
| Date | Nov 10, 2011 (initiated Sep 15, 2011) |
| Status | Terminated |
| Reason | A problem related to a software error has been detected in the Philips Multiple Gated Radionuclide Angiocardiography (MUGA) application. A false negative interpretation due to a falsely elevated ejection fraction or a false positive interpretation due to a false low ejection fraction could occur. |
| Root cause | Software design |
| Action | Philips sent all affected sites an Urgent Medical Device Correction Letter on September 27, 2011 for the MUGA issue. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the communication. Customers were asked to retain a copy of the communication with the equipment instruction for use. Additionally, a field change order was released on September 26, 2011, customers will be receiving release notes as part |
| Quantity | 1181 systems |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada. |
| FDA record | Open on fda.gov |