IntelliSpace Portal — Class II medical device recall Z-1678-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-06-11, distributed nationwide. During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is bei
| Recall number | Z-1678-2014 |
|---|---|
| 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 | 2014-03-11 |
| Classified | 2014-06-02 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2015-08-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, CA, CH, CL, DE, DK, ES, FI, FR, GB, IL, IN, IQ, IT, KY, LV, MX, MY, NL, PA, PE, PL, SA, SG, SK, TR |
| Quantity | 157 units |
| Serial numbers | 35033, 40001, 40003, 40021, 40024, 40031, 40033, 40036, 40044, 40061, 40082, 40084, 40087, 40088, 40093, 40096, 40133, 40134, 40141, 40145, 40146, 40148, 40150, 40155, 40158 and 74 more |
| Model numbers | 881001, 881030, 881035 |
Product
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.
Reason for recall
During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal. In addition, resolution recovery is not applied correctly in SPECT reconstructions using Astonish in AutoSPECT Pro on Intellispace Portal.
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-1678-2014. 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.