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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 91 of 91

Device	Model / Reference	Registries	Class	Status
Horizon Multi-Purpose Stretcher	462DPAST	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W8516	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD9207	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG8622	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W432	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566G1323	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U8602	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG8584	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U1319	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG6714	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566G454	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG1311	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566G6725	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U6727	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566G409	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD9214	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD6725	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG9212	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U8604	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG401	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W6724	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG1315	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W6714	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W8567	EUDAMEDFDA UDI	Class I	Active
Hausted	HSS500-S	EUDAMEDFDA UDI	Class I	Active
Hausted	4E2DPAST	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG8567	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U9212	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD6717	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG9208	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P8604	EUDAMEDFDA UDI	Class I	Active
Hausted	462EMPST	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG9202	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P9207	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W9202	EUDAMED	Class I	Active
Lumex	FR601U9205	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG432	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W8604	EUDAMEDFDA 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.