PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 12, 2018 Initiated: June 28, 2018 #Z-2961-2018

Product Description

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

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.

Details

Recalling Firm
Bayer Medical Care, Inc.
Units Affected
1
Distribution
The devices were distributed to the following US states: OH, TX, and WV.
Location
Indianola, PA

Frequently Asked Questions

What product 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. Recalled by Bayer Medical Care, Inc.. Units affected: 1.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 12, 2018. Severity: Moderate. Recall number: Z-2961-2018.