FDA-Device2018-09-12Class II
Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
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
4
Manufactured in
1 Bayer Dr, N/A, Indianola, PA, United States
Products
Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2962-2018Don't want to check this manually?
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