IntelliSpace Portal — Class II medical device recall Z-2237-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-08-20, distributed in AK, AL, AR, AZ, CA, CO, FL, GA…. The following software issues have been identified in the affected products. Problem 1: When reopening a bookm
| Recall number | Z-2237-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2014-07-27 |
| Classified | 2014-08-14 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2016-02-02 |
| Distributed | 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 |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GR, GT, HK, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KE, KR, KY, LB, LT, LV, MA, MX, MY, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RU, SA, SE, SG, SK, TH, TN, TR, TW, UA, VN, ZA |
| Quantity | 1,099 units |
| Reason classes | software |
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 for recall
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 (
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2237-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.