Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2739-2018Class II

VitalGo Total Lift Bed VG-TLB425T-TQR, Version 71064V0-27003

Vitalgo Inc. / initiated 2018-04-12 / Terminated

Vitalgo Inc. began a recall of VitalGo Total Lift Bed VG-TLB425T-TQR, Version 71064V0-27003 on . FDA classified it as Class II and gives the reason as "Potential for unintentional movement of the support surface of the bed from tilted position to horizontal position or any position in between". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2739-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Vitalgo Inc.
Product
VitalGo Total Lift Bed VG-TLB425T-TQR, Version 71064V0-27003
Product code
FNL Bed, Ac-Powered Adjustable Hospital
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 root cause
Component change control
Action
The 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 commerce
85 units
Distribution
US distribution to Texas.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2739-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2739-2018Class IITerminatedVoluntary: Firm initiated