Extended Brilliance Workspace NM Special Nuclear medicine image… — Class II medical device recall Z-1505-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-04-27, distributed in CO, DE, FL, GA, IL, IN, KS, MO…. The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors posi
| Recall number | Z-1505-2016 |
|---|---|
| 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 | 2016-03-04 |
| Classified | 2016-04-15 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2018-07-02 |
| Distributed | CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN, TX |
| Countries outside the US | AT, AU, BE, CA, CH, CN, DE, DK, EG, FR, GB, GR, IE, IL, IT, LB, MY, SA, SI, TR, ZA |
| Quantity | 37 units |
Product
Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. 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.
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-1505-2016. 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.