• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall SIZEWise Rentals LowBoy Bed

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall SIZEWise Rentals LowBoy Bed see related information
Date Initiated by Firm November 14, 2005
Date Posted May 25, 2006
Recall Status1 Terminated 3 on December 20, 2007
Recall Number Z-0908-06
Recall Event ID 35061
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product Low-Boy Bed, AC-powered adjustable hospital bed with a low position of 7'' to a high position of 30''. The beds are distributed by SIZEWise Rentals, Ellis, KS.
Code Information The serial numbers will be listed in the following format: SIZEWise number/Wheelchairs of Kansas number  22639/212666; 23243/212849; 22493/212646; 23245/212851; 21244/212428; 21254/212438; 22132/212502; 22140/212510; 22141/212511; 22142/212512; 22139/212509; 24403/213406; 22640/212667; 21251/212435; 23227/212860; 23228/212868; 23229/212869; 23257/212878/ 24384/213086; 24385/213087; 24398/213282; 24409/213412; 21252/212436; 22128/212498; 22636/212644; 23256/212879; 22502/212655; 22630/212658; 22642/212669; 21245/212429; 22129/212499; 23262/213073; 24401/213285; 22126/212496; 22496/212649; 23232/212863; 23239/212858; 23240/212846; 24402/213286; 23226/212871; 22135/212505; 22137/212507; 23246/212852; 23247/212853; 23248/212854; 23241/212847; 23260/213071; 23274/213084; 24387/213089; 23271/213081; 24396/213080; 22635/212663; 24411/213414; 24413/213416; 24414/213417; 24415/213418; 24416/213419; 24417/213420; 24418/213421; 24419/213425; 24420/213426; 24421/213427; 24422/213428; 25360/213429; 25361/213430; 25362/213431; 25363/213432; 25364/213433; 25365/213434; 25366/213435; 25367/213436; 25368/213437; 22136/212506; 22492/212631; 22638/212665; 22643/212670; 21240/212423; 21241/212424; 21246/212430; 22631/212659; 22632/212660; 22644/212874; 22646/212872; 23261/213072; 23263/213074; 23264/213075; 23265/212875; 23267/213077; 24391/213275; 24397/213281; 24399/213283; 21242/212425; 22498/212651; 23266/213076; 24400/213284; 24407/213410; 24408/213411; 21247/212431; 22495/212648; 23231/212866; 23234/212865; 24390/213123; 24389/213122; 24388/213121; 21253/212437; 23242/212848; 22134/212504; 22138/212508; 23249/212855; 23250/212856; 23251/212857; 23258/212877; 23259/212876; 22499/212652; 22500/212653; 22501/212654; 22628/212656; 22629/212657; 23233/212864; 23236/212861; 23237/212860; 24394/213278; 24395/213279; 21240/212423; 22497/212650; 24393/213277; 24405/213408; 24406/213409; 22127/212497; 22494/212647; 23230/212867; 23238/212859; 23255/212880; 24392/213276; 21249/212433; 21255/212439; 22131/212501; 22637/212671; 23252/212969; 23254/213070; 23270/213080; 24383/213085; 24386/213088; 23235/212862; 23244/212850; 22133/212503; 23253/212970; 23269/213079; 22130/212500; 22634/212662; 22645/212873; 24404/213407; 24410/213413; 22633/212661; 23272/213082; 23273/213083.
Recalling Firm/
Manufacturer
Rayes Inc
204 W 2nd Street
PO BOX 320
Ellis KS 67637-0320
For Additional Information Contact Eric D. Boss
800-537-6454 Ext. 2100
Manufacturer Reason
for Recall
The bed may drop due to a malfunction of the actuator exceeding its stop.
FDA Determined
Cause 2
Other
Action The recalling firm met with their one customer on/about 11/14/05 explaining the reason for correction. The customer then notified their company stores and dealers via service bulletin dated 2/28/06 that they would be receiving new acutators for replacement on the beds. The actuators were sent to their company stores and dealers in early March.
Quantity in Commerce 161 beds
Distribution The beds were shipped to the nationwide customers of their one consignee who is located in KS.
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.
-
-