Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0732-2017Class II

Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat...

GF Health Products, Inc. / initiated 2016-09-30 / Terminated / root cause: manufacturing process

GF Health Products, Inc began a recall of Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0732-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GF Health Products, Inc.
Product
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
Product code
FNL Bed, Ac-Powered Adjustable Hospital
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.
Root cause tag
manufacturing process
FDA 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 [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].
Quantity in commerce
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.
Product codes and lots
BED SERIAL NUMBER RANGE US0458 / US0468 Patriot Full Electric 120V 697142145108 through 697142147927 US0458 / US0468 Patriot Full Electric 220V 697144140132 through 697144140172 US6000 Patriot LX Full Electric 120V 69204141262 through 69204141737   SERVICE MOTOR KITS WITH SHIP DATES OF MAY 4, 2015 THROUGH JUNE 30, 2016 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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0732-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0732-2017Class IITerminatedVoluntary: Firm initiated