Bayer Medical Care Recalls Overhead Counterpoise Systems Due to Structural Risk
Bayer Medical Care is recalling four 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 vehicle/medical device defect where overtightened bolts may compromise structural integrity, leading to potential injury, which aligns with the 'Severe' criteria for structural defects.
Plain-English summary
Bayer Medical Care, Inc. is recalling four units of the Overhead Counterpoise Systems (OCS), specifically the 580mm Ceiling Mount Portegra2 model (Catalog # OCS CEIL 58, Material Number 84433765). The affected units have serial numbers 917/21956, 516/21035, 817/21916, and 817/21910. These 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 found to be outside of the torque specification. This error potentially overtightened the bolts on the ceiling column assembly. The 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.
The U.S. Food and Drug Administration has classified this as a Class II recall. Users of these devices should contact Bayer Medical Care, Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
- Manufacturer
- Bayer Medical Care, Inc.
- Affected units
- 4
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 (4)
- Serial Numbers: 917/21956
- 516/21035
- 817/21916
- 817/21910
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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