GE Healthcare Infinia — Class II medical device recall Z-0184-2015
Terminated recall by GE Healthcare, LLC, reported 2014-11-19, distributed nationwide. GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the
| Recall number | Z-0184-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-10-14 |
| Classified | 2014-11-07 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2015-02-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IR, IT, JP, KR, KW, LB, LT, LV, MA, MT, MX, MY, NL, NO, NZ, PA, PE, PH, PK, PL, PT, QA, RO, RU, SA, SE, SG, SK, TH, TN, TR, TW, UA, UY, VE, ZA |
| Quantity | 2,479 |
| UPC / GTIN / UDI-DI | 83026002000469, 83026002002289, 83026062102318, 83026206522477, 83026801003210, 83026805120043, 83026862100378 |
| Model numbers | H2400YJ, H2400YK, H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H3000WZ, H3000YF, H3000YG, H3000YM, H3000YS |
Product
GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H3000WZ, H3000YF, H3000YG, H3000YM, H3000YS, H2400YJ, H2400YK. Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
Reason for recall
GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
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-0184-2015. 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.