Recall Z-2237-2014 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Wor
| Date | Aug 14, 2014 (initiated Jul 27, 2014) |
| Status | Terminated |
| Reason | The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application, the ejection fraction (EF) displayed should be the same as the ejection fraction (EF) originally displayed when the bookmark was first created. In some instances, the ejection fraction ( |
| Root cause | Software design |
| Action | Philips Healthcare issued an Urgent Medical Device Correction letter dated July 28, 2014, via certified mail to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Philips Key Market representative would distribute the FSN internationally. Additionally, a Field Service Engineer would contact each site to schedule a time to install the software update. Customers with questions were instructed to contact their local Philips representataive or local Philips Healthcare office. For North America and Canada customers were instruc |
| Quantity | 1099 Units |
| Distribution | Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VT, WA, WI, WV, WY,Washington D.C. and Internationally to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Be |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012009 | MX8000 IDT CT SYSTEM Marconi Medical Systems, Inc., Sep 13, 2001 |
| K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc., Oct 29, 2003 |
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |
| K110151 | ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T Philips Health Care, Mar 22, 2011 |