FDA-Device2018-09-12Class II
Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
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
2
Manufactured in
1 Bayer Dr, N/A, Indianola, PA, United States
Products
Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2960-2018Don't want to check this manually?
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