Home / Recalls / Medical Devices
Bayer Medical Care, Inc. recalls Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 8443376
Recalled September 12, 2018 · FDA recall Z-2962-2018 · Bayer Medical Care
Hazard
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. · FDA Class II
Units
4
Sold at
The devices were distributed to the following US states: OH, TX, and WV.
Description
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.
Product
Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
Manufacturer(s)
Bayer Medical Care, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →