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U.S. Department of Health and Human Services

Class 2 Device Recall VitalGo Total Lift Bed

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 Class 2 Device Recall VitalGo Total Lift Bedsee related information
Date Initiated by FirmApril 12, 2018
Create DateAugust 09, 2018
Recall Status1 Terminated 3 on March 12, 2019
Recall NumberZ-2739-2018
Recall Event ID 80495
Product Classification ac powered bed - Product Code FNL
ProductVitalGo Total Lift Bed VG-TLB425T-TQR, Version 71064V0-27003
Code Information Model Number TLB425T-TQR; Serial Number A612, A617, A622, A629, A650, A651, A655, A657, A690, A742, A773, A791, A792, A793, A794, A603, A615, A621, A668, A673, A785, A786, A787, A788, A789, A790, A678, A679, A680, A682, A684, A685, A774, A795, A796, A798, A799, A800, A801, A802, A803, A804, A805, A806, A807, A808, A809, A810, A811, A812, A813, A814, A815, A816, A817, A818, A819, A820, A821, A822, A823, A824, A825, A826, A827, A828, A829, A831, A832, A833, A834, A835, A836, A837, A842, A843, A844, A845, A846, A847, A848, A849, A850, A851, A852 
Recalling Firm/
Manufacturer		 Vitalgo Inc.
3520 NW 56th St Ste 303
Fort Lauderdale FL 33309-2229
For Additional Information ContactMr. Ohad Paz
954-990-4632
Manufacturer Reason
for Recall		Potential for unintentional movement of the support surface of the bed from tilted position to horizontal position or any position in between.
FDA Determined
Cause 2		Component change control
ActionThe customer was notified of the recall on about 04/12/2018 via letter. The letter was follow up to previous communications on 02/19/2018, 03/06/2018, 03/07/2018, 03/26/2018, and 04/09/2018 and reminded the customer that all affected beds at each service center are to be placed on Quality Hold. Further directions will be provided at a later time to conduct a correction on the beds.
Quantity in Commerce85 units
DistributionUS distribution to Texas.
Total Product Life CycleTPLC 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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