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GF Health Products, Inc

United States·US-MF-000002167

Last updated September 17, 2026

Information

Country: United States
Address: One Graham Field Way, Atlanta, United States
Website: www.grahamfield.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +17703684700
PRRC Contact: Amy Piccini
EUDAMED SRN: US-MF-000002167
FDA FEI Number: 2427360
DUNS Number: —

Catalogue (4538)

Page 28 of 91

Device	Model / Reference	Registries	Class	Status
Lumex	FR597G1326	FDA UDI	Class I	Active
Intensa	744-T4	FDA UDI	Class I	Active
Intensa	IN587WCRS50	FDA UDI	Class I	Active
Lumex	FR566GH409	FDA UDI	Class I	Active
Intensa	IN566DG6717	FDA UDI	Class I	Active
Intensa	460-FS-AA-PS-TL	FDA UDI	Class I	Active
Lumiscope	100-510LA	FDA UDI	Class II	Active
Intensa	IN566G-T3	FDA UDI	Class I	Active
Intensa	IN601UHAL	FDA UDI	Class I	Active
Everest & Jennings	9P835228J	FDA UDI	Class I	Active
Intensa	IN577RGH8567PA	FDA UDI	Class I	Active
Intensa	748B-NA	FDA UDI	Class I	Active
Everest & Jennings	3F012130	FDA UDI	Class I	Active
Intensa	IN577RG454	FDA UDI	Class I	Active
Intensa	IN566DGHBLPA	FDA UDI	Class I	Active
Grafco	1697-1	FDA UDI	Class I	Active
Everest & Jennings	3H020100	FDA UDI	Class I	Active
Everest & Jennings	3F020220	FDA UDI	Class I	Active
Lumex	FR587WD9205PA	FDA UDI	Class I	Active
Intensa	IN587WDPMPA	FDA UDI	Class I	Active
Grafco	2716	FDA UDI	Class I	Active
Intensa	IN566G6714PA	FDA UDI	Class I	Active
Lumex	7927A	FDA UDI	Class I	Active
Intensa	460-FS-DW-SH	FDA UDI	Class I	Active
Lumex	FR597G1329	FDA UDI	Class I	Active
Intensa	IN566DG409PA	FDA UDI	Class I	Active
LabTron	200	FDA UDI	Class II	Active
Intensa	420-EO-T2	FDA UDI	Class I	Active
Lumex	FR566G8810	FDA UDI	Class I	Active
Intensa	IN587WH6724PA	FDA UDI	Class I	Active
Intensa	IN566G8584PA	FDA UDI	Class I	Active
Intensa	IN577RG1304	FDA UDI	Class I	Active
Labtron	300DLX-R	FDA UDI	Class I	Active
Hausted	4200-DW-BT	FDA UDI	Class I	Active
Intensa	IN587W8602PA	FDA UDI	Class I	Active
Everest & Jennings	90763065	FDA UDI	Class I	Active
Grafco	3786B#2	FDA UDI	Class I	Unknown
Everest & Jennings	90763430	FDA UDI	Class I	Unknown
Intensa	460-AA-PS-MO	FDA UDI	Class I	Active
Intensa	420-EO-T6	FDA UDI	Class I	Active
Intensa	IN577RGHBTPA	FDA UDI	Class I	Active
Intensa	744B-WH	FDA UDI	Class I	Active
Hausted	4200-BT	FDA UDI	Class I	Active
Lumex	FR566DG1325PA	FDA UDI	Class I	Active
Hausted	4200-EO-VI	FDA UDI	Class I	Active
Intensa	IN566DG454PA	FDA UDI	Class I	Active
Lumex	FR587WH1315	FDA UDI	Class I	Active
Hausted	6200DA-WW	FDA UDI	Class I	Active
Lumex	FR566G8516PA	FDA UDI	Class I	Active
Everest & Jennings	8920228	FDA UDI	Class I	Active

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 24, 2021	Z-1353-2021	—	terminated	The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.
Sep 30, 2016	Z-0732-2017	—	terminated	GF Health Products, Inc., in conjunction with OKIN America, has initiated a voluntary field correction affecting the OKIN America "DUOMAT 3" Head/Foot motor used in the manufacture of our Lumex Patriot Full Electric Bed Model US0458/US0468 and Patriot LX Full Electric Bed Model US6000. The failure mode is directly related to contaminated material in the plastic housing used to produce the DUOMAT 3 motor. Contaminated motor housings may crack resulting in a motor that will no longer actuate the head section per the intended design. If the head section were to fall it is unlikely but possible an injury could occur. No injuries have been reported.
Sep 14, 2009	Z-0139-2010	—	terminated	Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications.