Device product
TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device
Z-0942-2017
Product summary
- Event
- Event 75881
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,343 chairs
- Official record key
device-enforcement:Z-0942-2017
Official wording
Reason: The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle.
Code information: Numerous serial numbers affected (12,343 units)
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle.