Bayer Medical Care, Inc. recalls Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for a…

Recall date

June 28, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2961-2018

FDA classification

Class II

Brand / firm

Bayer Medical Care, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material Number 59880288