CLASS II Device recall · Reported 12 Sep 2018 · FDA Enforcement Report

Overhead Counterpoise Systems recalled by Bayer Medical Care

Bayer Medical Care is recalling Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer, distributed in Ohio, Texas, West Virginia. The recall was initiated on 28 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number: 4061630901

Quantity recalled1

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2961-2018
FDA event ID: 80727
Recalling firm: Bayer Medical Care, Indianola, PA
Classification: Class II
Status: Terminated
Recall initiated: 28 Jun 2018
FDA classified: 31 Aug 2018
Reported: 12 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 Jun 2018	Recall initiated by company
31 Aug 2018	Classified by FDA	+64 days
12 Sep 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

The devices were distributed to the following US states: OH, TX, and WV.

Ohio Texas West Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Number: 4061630901

Where was it sold?

The devices were distributed to the following US states: OH, TX, and WV.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 80727

Reported	Class	Recall	Company	Reason	Where
12 Sep 2018	CLASS II	Overhead Counterpoise Systems (Ocs), Ocs Ceiling Mount, PORTEGRA2 recalled	Bayer Medical Care	Other	OH, TX, WV
12 Sep 2018	CLASS II	Overhead Counterpoise Systems (Ocs), Ocs Conf,Std Ceil Mnt recalled	Bayer Medical Care	Other	OH, TX, WV

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