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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 90 of 91

Device	Model / Reference	Registries	Class	Status
Lumex	FR566DG9715	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566G401	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD1319	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U427	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG8604	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG1318	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U9516	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG8808	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD9212	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG8604	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U1304	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W8584	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG9207	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG9764	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U1311	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG8602	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WDBU	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P427	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W8622	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG6727	EUDAMEDFDA UDI	Class I	Active
Hausted	462APAST	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566G9208	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W1305	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566G432	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W9205	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P409	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG9205	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG8516	EUDAMEDFDA UDI	Class I	Active
Hausted	MBC000ST	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD1304	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U1325	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P6724	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P454	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P1318	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P8602	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG1323	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P432	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U1305	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG9214	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P9205	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD9210	EUDAMEDFDA UDI	Class I	Active
Hausted	4160DOST	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD8567	EUDAMEDFDA UDI	Class I	Active
Hausted	HSS500-WD	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG8809	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W427	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P9208	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W9214	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD401	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566G9212	EUDAMEDFDA UDI	Class I	Active

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Authorised Representatives

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Authorities

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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.