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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2739-2018 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
