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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- 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
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.
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