| Date Initiated by Firm |
September 30, 2016 |
| Create Date |
December 12, 2016 |
| Recall Status1 |
Terminated 3 on April 29, 2019 |
| Recall Number |
Z-0732-2017 |
| Recall Event ID |
75460 |
| Product Classification |
Bed, ac-powered adjustable hospital - Product Code FNL
|
| 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 |
| Code Information |
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 |
Recalling Firm/
Manufacturer |
GF Health Products, Inc
336 Trowbridge Dr
Fond Du Lac WI 54937-9103
|
| For Additional Information Contact |
888-974-4347
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
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 information, please call 1-888-974-4347; or at fieldcorrection@grahamfield.com. |
| 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. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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