Philips Medical Systems — Class II medical device recall Z-0883-2013
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-03-06, distributed in AK, AZ, CA, CO, CT, DC, DE, FL…. Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanni
| Recall number | Z-0883-2013 |
|---|---|
| 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 | 2012-10-24 |
| Classified | 2013-02-26 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2015-07-23 |
| Distributed | AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | CA |
| Quantity | 37 |
| Reason classes | labeling, software |
| Serial numbers | 9004, 9005, 9006, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206, 9207 and 12 more |
| Model numbers | 882476 |
Product
Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Reason for recall
Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project
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-0883-2013. 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.