Data Foundry

Medical device recalls 2015

GEMINI TF PET/CT 64 Slice — Class II medical device recall Z-1787-2015

Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-06-17, distributed nationwide. The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomograp

Recall numberZ-1787-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Medical Systems (Cleveland) Inc, Cleveland, OH, United States
Recall initiated2015-03-06
Classified2015-06-11
Reported by FDA2015-06-17
Terminated2017-03-13
DistributedNationwide (US)
Countries outside the USAE, AR, AT, AU, BD, BE, BG, BO, BR, CH, CN, CO, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GH, GR, GT, HK, HR, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, KY, LB, LK, LT, LU, LV, MA, MT, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PH, PK, PL, PT, PY, RO, RS, RU, SA, SE, SG, SK, TH, TN, TR, TW, UA, VE, VN, ZA
Quantity71 units
Reason classespackaging, device malfunction
Serial numbers7037, 7205, 7206, 7209, 7212, 7213, 7214, 7217, 7218, 7219, 7221, 7227, 7229, 7231, 7234, 7238, 7241, 7245, 7251, 7252, 7253, 7254, 7255, 7256, 7257 and 46 more
Model numbers882471

Product

GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

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-1787-2015. 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.