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Recall Observatory FDA recall evidence

Device product

Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253

Z-2960-2018

June 28, 2018

Class II

Product summary

Firm
Bayer Medical Care, Inc.
Event
Event 80727
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-2960-2018

Official wording

Reason: 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.

Code information: Serial Numbers: 11051103902, 305746202

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.