Bayer Medical Care, Inc.: 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.

Agency Publication Date: August 31, 2018

Affected Products

Product: Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material Number 59880288

Serial Number: 4061630901

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

Serial Numbers: 11051103902, 305746202

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

Serial Numbers: 917/21956, 516/21035, 817/21916, 817/21910

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80727

Status: Resolved

Manufacturer: Bayer Medical Care, Inc.

Manufactured In: United States

Units Affected: 3 products (1; 2; 4)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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