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Terminated

Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912

FDA Recall Z-0732-2017 · Posted None

Recall StatusTerminated
Product CodeFNL
Date Initiated2016-09-30
Date Terminated2019-04-29
Product Quantity3,547 (3063 beds, 484 motors)

Reason for Recall

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.

Firm Action

Graham Field sent an "Urgent Correction" letter dated September 30, 2016. The letter described the problem and the product involved in the recall. The letter described the " Action Required: Motor Replacement" . Informed consignees to contact GF Health Products at 1-888-974-4347 or [email protected] within ten (10) business days from receipt of this notification to schedule motor replacement order. Requested consignees to return the completed Certification of Replacement and Return Agreement to: [email protected] or Fax: 1-920-929-8213. For additional information, please call 1-888-974-4347; or at [email protected].

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - USA ( nationwide) Distribution including Puerto Rico and to the countries of : Bahamas, Canada, Chile, El Salvador and Santo Domingo.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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