Recall Z-2962-2018— Bayer Medical Care, Inc.

Name: FDA recall Z-2962-2018
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: K934206. Product: Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765. 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

K934206 — MAVIG ANGIO SHIELD MODELS 6290 & 6272F. Walter Hanel GmbH·cleared 1993-10-07

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, 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.

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