510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0908-06

Low-Boy Bed, AC-powered adjustable hospital bed with a low position of 7'' to a high position of 30''. The...

Agiliti Health - Hays / initiated 2005-11-14 / Terminated
FDA source (opens on fda.gov)

Rayes Inc began a recall of 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 on . The reason FDA records is "The bed may drop due to a malfunction of the actuator exceeding its stop". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0908-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Agiliti Health - Hays
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.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
The bed may drop due to a malfunction of the actuator exceeding its stop.
FDA root cause
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.
Product codes and lots
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.