GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle… — Class I medical device recall Z-1787-2013
Terminated recall by GE Healthcare, LLC, reported 2013-07-31, distributed nationwide. GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuri
| Recall number | Z-1787-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-06-13 |
| Classified | 2013-07-23 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2014-06-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AF, AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KR, KW, LB, LT, LV, MA, MT, MX, MY, NL, NO, NZ, PA, PE, PH, PK, PL, PT, RO, RU, SA, SE, SG, SK, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 2,474 |
| UPC / GTIN / UDI-DI | 00082426030021, 00082426040037, 00082426050005, 00082426080019, 00082426090018, 00082426100038, 00082426110006, 00082426130035, 00082426150019, 00082426160025, 00082426160032, 00082426180009, 00082426190015, 00082426200004, 00082426230018, 00082426270007, 00082426290005, 00082426310024 |
Product
GE Healthcare Infinia 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 became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.
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-1787-2013. 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.