FDA Device recall Z-0882-2013
Philips Medical Systems, GEMINI LXL - Model #882412
- FDA Device
- Class II
- terminated
- Published 2013-03-06
On 2013-03-06 the FDA classified a Class II recall of Philips Medical Systems, GEMINI LXL - Model #882412 by Philips Medical Systems Cleveland, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0882-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-24 |
| Published | 2013-03-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | 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 |
Product
Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Reason
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
Identifiers
| code_info | The affected GEMINI systems are identified with the following Serial Numbers: GEMINI LXL Model # 882412, Serial Numbe…The affected GEMINI systems are identified with the following Serial Numbers: GEMINI LXL Model # 882412, Serial Numbers: 14702 and 14707; GEMINI TF 16 Model #882470, Serial Numbers: 7129, 7121, 7123, 7128, 7096, 7133, 7185, 7187, 7226, and 7220; GEMINI TF 16, Model #882473, Serial Numbers: 7150, and and 7237;GEMINI TF 64, Model #882471, Serial Numbers: 7103, 7126, 7132, 7158, 7160, 7164, 7175, 7178, 7179, 7218, 7229, 7221, 7245, 7550, 7255, and 7256. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0882-2013%22
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