Recall Z-2960-2018— Bayer Medical Care, Inc.

Name: FDA recall Z-2960-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-28

Class II · Terminated

Class II FDA medical device recall by Bayer Medical Care, Inc., initiated 2018-06-28, terminated 2018-11-26. It names one FDA 510(k) clearance: K944983. Product: Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253. Reason: 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..

Recalling firm: Bayer Medical Care, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-06-28
Terminated: 2018-11-26
Firm location: Indianola, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K944983 — MEDRAD COUNTERPOISE SYSTEMMedrad, Inc.·cleared 1994-11-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.