Diagnostic imaging systems — Class II medical device recall Z-0932-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-02-12, distributed in AL, AR, AZ, CA, CO, DC, FL, GA…. The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complet
| Recall number | Z-0932-2014 |
|---|---|
| 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 | 2013-12-04 |
| Classified | 2014-02-04 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2016-02-02 |
| Distributed | AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI |
| Countries outside the US | AU, BE, BG, BR, CA, CH, CN, DE, DK, EG, ES, FR, GB, HK, HR, HU, ID, IN, IT, JP, KR, KW, LB, MT, MX, NL, PH, PK, PL, PT, RU, SA, SE, SG, SK, TH, TR, TW, UA, VE, VN |
| Quantity | 386 units |
| Serial numbers | 14702, 14704, 14705, 14706, 14707, 14708, 14709, 14710, 14711, 17003, 17004, 17005, 17006, 17007, 17008, 17009, 17010, 17011, 17012, 17013, 17014, 17015, 17017, 17018, 17019 and 358 more |
| Model numbers | 882412, 882438, 882470, 882471, 882473, 882476 |
Product
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)
Reason for recall
The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study.
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-0932-2014. 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.