GE Healthcare Quasar Nuclear Medicine System — Class II medical device recall Z-1078-2013
Terminated recall by GE Healthcare, LLC, reported 2013-04-17, distributed nationwide. Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System co
| Recall number | Z-1078-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-03-06 |
| Classified | 2013-04-10 |
| Reported by FDA | 2013-04-17 |
| Terminated | 2014-01-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CN, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IR, IT, JO, JP, KR, KW, LB, LT, LV, MA, MT, MX, MY, NL, NO, NZ, PA, PH, PK, PL, PT, SA, SE, SG, TH, TN, TR, TW, UA, UY, VE, ZA |
| Quantity | 2,180 |
| UPC / GTIN / UDI-DI | 00082426030021, 00082426040037, 00082426050005, 00082426080019, 00082426090018, 00082426100038, 00082426110006, 00082426150019, 00082426160025, 00082426160032, 00082426180009, 00082426190015, 00082426200004, 00082426270007, 00082426290005 |
Product
GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.
Reason for recall
Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators.
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-1078-2013. 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.