IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT…
Medical device recall Z-2237-2014. Published in FDA’s Enforcement Report on Aug 20, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 20, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 37 states named in where it went
- 1099 Units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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 (
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
1099 Units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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 79932 87017 87161 82099 85331 82145 81089 85025 85252 82093 87165 85165 81034 82035 85080 822020 87167 85031 35030 35009 80911 80965 870034 82086 82085 82082 81160 87170 87180 87003 95068 81063 82236 82006 360006 870053 81173 87182 87197 85026 870040 95071 82120 95029 82089 82124 87205 87192 95032 95005 87001 870082 950130 95037 87179 870050 870104 870106 870105 870043 360005 870076 82140 80991 85383 95010 81111 95021 85266 95036 82241 87194 870110 870012 870041 850015 87174 87191 87163 87150 870098 87189 87202 870109 87159 87200 870079 95075 870100 950153 95034 81171 870072 87178 81186 45007 95039 81188 950022 950116 85213 95007 87013 81117 95008 870049 950131 870092 950114 81008 870035 870026 87177 87172 87184 450009 950045 870074 950160 95069 870080 950096 87190 85314 85303 85256 85298 870038 870062 82148 95067 870108 310007 87198 95033 95065 870070 85235 870033 82135 142301 870028 82127 87171 870047 82201 87195 82134 82136 870102 870097 870042 950135 95025 85313 87185 310006 80071…
FDA’s list runs to 6,974 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Congo, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Viet Nam, and Yemen.
The states and territories these words name
37 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- District of Columbia
- Florida
- Georgia
- Illinois
- Indiana
- Kansas
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 27, 2014.
- FDA classified it on Aug 14, 2014.
- FDA’s Enforcement Report published it on Aug 20, 2014.
- FDA terminated it on Feb 2, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Medical Systems (Cleveland) Inc, of Cleveland, OH.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 6,974 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.