# FDA recall Z-2961-2018

> **Bayer Medical Care, Inc.** · Class II · device recall initiated 2018-06-28.

## 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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-2961-2018
- **Recalling firm:** Bayer Medical Care, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-28
- **Report date:** 2018-09-12
- **Termination date:** 2018-11-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianola, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2961-2018

## Citation

> AI Analytics. FDA recall Z-2961-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-2961-2018. Source: US FDA. Licensed CC0.

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