Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
Check against the official notice below — it lists the full affected range.
Bayer Medical Care, Inc. is recalling two Overhead Counterpoise Systems (OCS) with catalog number OCS 115A due to a safety concern discovered during a service visit. A torque wrench used to tighten bolts on the ceiling column assembly was operating outside proper specifications, which may have overtightened the bolts and compromised the structural integrity of the system. If the structural integrity is compromised, the OCS could disengage from its ceiling mount, potentially injuring patients or operators.
The affected devices have serial numbers 11051103902 and 305746202 and were distributed to facilities in Ohio, Texas, and West Virginia. The recall source does not specify what remedy consumers should undertake.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: The devices were distributed to the following US states: OH, TX, and WV. Quantity: 2 Lot/code info: Serial Numbers: 11051103902, 305746202
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.