FDA (Devices) recall action 80727
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Bayer Medical Care is recalling four Overhead Counterpoise Systems because overtightened bolts may compromise structural integrity, posing a risk of injury.
Bayer Medical Care is recalling one Overhead Counterpoise System unit due to potential overtightening of bolts that could compromise structural integrity.
Bayer Medical Care is recalling two Overhead Counterpoise Systems because overtightened bolts may compromise structural integrity, posing a risk of injury.