Data Foundry

Medical device recalls 2015

GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740 — Class II medical device recall Z-1975-2015

Terminated recall by GE Healthcare, reported 2015-07-08, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantr

Recall numberZ-1975-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmGE Healthcare, Waukesha, WI, United States
Recall initiated2015-05-29
Classified2015-07-02
Reported by FDA2015-07-08
Terminated2015-10-28
DistributedNationwide (US)
Countries outside the USAR, BE, BR, CA, CL, CN, DE, FR, GB, HK, HU, ID, IN, IT, JP, RU, VN
Quantity3

Product

GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

Reason for recall

GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).

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-1975-2015. 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.