Kenex Radiation Shield and surgical lamps installed with GE… — Class II medical device recall Z-1706-2014
Terminated recall by GE Healthcare, LLC, reported 2014-06-11, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kene
| Recall number | Z-1706-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-05-02 |
| Classified | 2014-06-03 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2015-02-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KR, KW, LB, LT, LV, MA, MT, MX, MY, NG, NI, NL, NO, NZ, OM, PA, PH, PK, PL, PT, PY, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| UPC / GTIN / UDI-DI | 00000002010007, 00082406010005, 00082406040026, 00082406070009, 00082406090007, 00082406090014, 00082406090021, 00082406100010, 00082406110002, 00082406120001, 00082406120018, 00082406140016, 00082406150008, 00082406160007, 00082406160038, 00082406190004, 00082406190011, 00082406210009, 00082406250005, 00082406270003, 00082406290001, 00082406310006, 00082416010002, 00082416010019, 00082416020001 and 51 more |
| Model numbers | E03971AA |
Product
Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers: E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591HL;E30591EB;E30511P;E30591AB;E30591B;E30511Q;E30591C;E30591A;E30591RR;E30591CB;E30591E;E33591PA;E33591PC. Product Usage: Personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and surgical lamp. This issue is not related to the design of the Kenex product. The affected products are limited to installations completed or contracted by GE Healthcare. There has been a reported incident of a radiation shield falling from the ceil
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-1706-2014. 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.