The Recall Desk
SevereFDA (Devices)·Z-2961-2018·Announced 2018-09-12

Bayer Overhead Counterpoise Systems Recalled for Potential Structural Failure

Bayer Medical Care is recalling one Overhead Counterpoise System unit due to potential overtightening of bolts that could compromise structural integrity.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural vehicle defect equivalent (structural integrity of a medical device) where failure could lead to injury, meeting the criteria for a Severe (Score 4) classification.

Plain-English summary

Bayer Medical Care, Inc. is recalling one unit of the Overhead Counterpoise Systems (OCS) OCS CONF, an accessory device used with Bayer injector systems. The specific unit is identified by Catalog # OCS 115AS, Material Number 59880288, and Serial Number 4061630901. The device was distributed to facilities in Ohio, Texas, and West Virginia.

The recall was initiated because a torque wrench used during a recent service visit was outside of the specified torque range, potentially overtightening the bolts on the ceiling column assembly. This overtightening may compromise the structural integrity of the system, which could lead to the OCS disengaging from the ceiling mount. Such a failure may cause injury to the patient or the operator.

Healthcare facilities that received this specific unit should contact Bayer Medical Care, Inc. for instructions on how to proceed with the recall and ensure the safety of their equipment.

The recalled product

Product
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
Manufacturer
Bayer Medical Care, Inc.
Category
Medical Device — Surgical Support Equipment
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Number: 4061630901

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 3 recalled by Bayer Medical Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Bayer Medical Care, Inc.

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Same hazard · structural failure

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