FDA Device recall Z-2237-2014
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a mul…
- FDA Device
- Class II
- terminated
- Published 2014-08-20
On 2014-08-20 the FDA classified a Class II recall of IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a mul… by Philips Medical Systems Cleveland, citing 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 w….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2237-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-27 |
| Published | 2014-08-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | 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, PR, SC, TN, TX, VT, WA, WI, WV, WY |
Product
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 Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
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 (
Identifiers
| code_info | ISP DX/HX/EX; 881001 870081 85254 870044 870065 950104 85045 95027 82202 85319 87187 85170 85244 85218 95030 92003…ISP DX/HX/EX; 881001 870081 85254 870044 870065 950104 85045 95027 82202 85319 87187 85170 85244 85218 95030 92003 85166 85172 87162 85330 85337 85164 95038 950129 870037 87193 82117 80905 85042 920005 80864 95057 950094 85104 85359 950084 85180 950071 850001 87201 87014 85588 85607 85623 85619 80974 85578 80752 85628 85627 85637 85601 80898 85599 85594 85629 85585 85636 85668 85584 85617 85581 81135 85645 85634 85625 85600 85640 85630 85639 85616 85642 85582 85673 85618 85670 85676 85598 85422 85577 85580 85631 85678 85589 85644 85648 85653 85621 85626 85638 85620 85596 85597 85614 85641 85615 85595 85675 85647 85649 85650 85651 85652 85654 85622 85587 85427 80973 85426 80939 85624 85635 82247 85583 85613 85590 95058 87204 870067 87030 87029 870031 870099 870085 82238 87151 95066 82146 85307 85327 870030 870086 87158 85308 85309 870078 85168 85069 82094 950149 82018 82008 87166 82109 85394 85249 35023 82240 85108 85317 36001 85311 870032 82141 82098 82237 81076 870052 81119 82118 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2237-2014%22
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