Bayer Medical Care, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2960-2018)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2018.
Data Source: FDA.
Product Description:
Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
Product Classification:
Class II
Date Initiated: June 28, 2018
Date Posted: September 12, 2018
Recall Number: Z-2960-2018
Event ID: 80727
Reason for Recall:
The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.
Status: Terminated
Product Quantity: 2
Code Information:
Serial Numbers: 11051103902, 305746202
Distribution Pattern:
The devices were distributed to the following US states: OH, TX, and WV.
Voluntary or Mandated:
Voluntary: Firm initiated