Recall Z-0732-2017 ยท FNL Bed, Ac-Powered Adjustable Hospital
GF Health Products, Inc
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 Moto
| Date | Sep 30, 2016 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Process control |
| 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 fieldcorrection@grahamfield.com 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: fieldcorrection@grahamfield.com or Fax: 1-920-929-8213. For additional informatio |
| Quantity | 3,547 (3063 beds, 484 motors) |
| Distribution | Worldwide Distribution - USA ( nationwide) Distribution including Puerto Rico and to the countries of : Bahamas, Canada, Chile, El Salvador and Santo Domingo. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.