FDA-Device2018-09-12Class II
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
Bayer Medical Care, Inc.
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.
Sold states
The devices were distributed to the following US states: OH, TX, and WV.
Affected count
1
Manufactured in
1 Bayer Dr, N/A, Indianola, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2961-2018Don't want to check this manually?
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