Bayer Overhead Counterpoise Systems Recalled for Potential Structural Failure
Bayer Medical Care is recalling two Overhead Counterpoise Systems because overtightened bolts may compromise structural integrity, posing a risk of injury.
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 defect in a medical device that could lead to disengagement and injury, meeting the criteria for a Severe rating.
Plain-English summary
Bayer Medical Care, Inc. is recalling two units of Overhead Counterpoise Systems (OCS), Catalog # OCS 115A, Material Number 59880253. The devices were 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 torque specification, 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 and causing injury to the patient or the operator.
Affected units have serial numbers 11051103902 and 305746202. Users should contact Bayer Medical Care, Inc. for instructions on how to proceed with the recall.
The recalled product
- Product
- Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
- Manufacturer
- Bayer Medical Care, Inc.
- Affected units
- 2
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 (2)
- Serial Numbers: 11051103902
- 305746202
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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