FDA Device recall Z-1506-2016
IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications use…
- FDA Device
- Class II
- terminated
- Published 2016-04-27
On 2016-04-27 the FDA classified a Class II recall of IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications use… by Philips Medical Systems Cleveland, citing the AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1506-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-04 |
| Published | 2016-04-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN, TX |
Product
IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
Reason
The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.
Identifiers
| code_info | M/N 881001; S/N: 85254, 82202, 85330, 82117, 7000022, 105009, 970001, 850001, 870030, 82141, 95068, 87182, 87197, 95078…M/N 881001; S/N: 85254, 82202, 85330, 82117, 7000022, 105009, 970001, 850001, 870030, 82141, 95068, 87182, 87197, 95078, 82140, 11017, 98139, 95035, 87200, 980047, 85314, 85303, 980046, 85298, 822022, 7000019, 950076, 950115, 95043, 95047, 950021, 960123 & 105006. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1506-2016%22
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