Philips Medical Systems (Cleveland) Inc Recall: IntelliSpace Portal DX/HX/EX AutoSPECT Pro
Philips Medical Systems (Cleveland) Inc Recall: IntelliSpace Portal DX/HX/EX AutoSPECT Pro is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Philips Medical Systems (Cleveland) Inc; Product: IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Clevela
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
|---|---|
| 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 for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South A |
| Recall initiated | 20160304 |
| Recall number | Z-1506-2016 |
| Category | device |
| State | OH |
| Country | United States |
$29/mo
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