Home / Recalls / Bayer Medical Care, Inc. / Z-2960-2018

Z-2960-2018 Class II Terminated

Recalled by Bayer Medical Care, Inc. — Indianola, PA

Recall Details

Product Type
Devices
Report Date
September 12, 2018
Initiation Date
June 28, 2018
Termination Date
November 26, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

Product Description

Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253

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.

Distribution Pattern

The devices were distributed to the following US states: OH, TX, and WV.

Code Information

Serial Numbers: 11051103902, 305746202

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  • Z-2961-2018 Class II — Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Ba (June 28, 2018)
  • Z-2962-2018 Class II — Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalo (June 28, 2018)