Kenex Radiation Shield installed with GE Healthcare Interventional — Class II medical device recall Z-1441-2015
Terminated recall by GE Healthcare, reported 2015-04-22, distributed in CA, MA. GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting
| Recall number | Z-1441-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2015-03-09 |
| Classified | 2015-04-13 |
| Reported by FDA | 2015-04-22 |
| Terminated | 2015-12-21 |
| Distributed | CA, MA |
| Countries outside the US | BG, CH, CZ, DE, EG, ES, FI, FR, GB, GY, IE, IL, IN, IT, JP, NG, NO |
| UPC / GTIN / UDI-DI | 08301603078802, 08301622006008, 08301686210076 |
Product
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
Reason for recall
GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.
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-1441-2015. 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.