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

Overhead Counterpoise Systems (Ocs), Ocs Ceiling Mount, PORTEGRA2 recalled

Bayer Medical Care is recalling Overhead Counterpoise Systems (Ocs), Ocs Ceiling Mount, PORTEGRA2, 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 Numbers: 917/21956, 516/21035, 817/21916, 817/21910

Quantity recalled4

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-2962-2018
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: Lead & Heavy Metals
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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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

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

Is Overhead Counterpoise Systems (Ocs), Ocs Ceiling Mount, PORTEGRA2 recalled?

Yes. Bayer Medical Care recalled Overhead Counterpoise Systems (Ocs), Ocs Ceiling Mount, PORTEGRA2 on 28 Jun 2018. The recall is Class II and its status is Terminated. Recall number Z-2962-2018.

Why was it recalled?

Which lots are affected?

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

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

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