Device product
The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.
Z-0371-2017
Product summary
- Event
- Event 75288
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 surgical tables with defective floor locking cylinders were distributed. Each table contains 3 cylinders for a total of 12 cylinders.
- Official record key
device-enforcement:Z-0371-2017
Official wording
Reason: The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect "O" ring which may cause the cylinder to leak.
Code information: Lot Codes for the four (4) model 7300 Surgical Tables TFX-1653, TFX1654, TFX1655, TFX1656
Distribution pattern: Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA, and VA Replcement cylinders wre distributed
Derived failure modes
-
Unknown
The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect "O" ring which may cause the cylinder to leak.