FDA recall Z-2962-2018

Product

Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765

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.

Key facts

Status

Terminated

Initiation date

2018-06-28

Report date

2018-09-12

Termination date

2018-11-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianola, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2962-2018