FDA Device recall Z-2961-2018
Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , S…
- FDA Device
- Class II
- terminated
- Published 2018-09-12
On 2018-09-12 the FDA classified a Class II recall of Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , S… by Bayer Medical Care, citing 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 overtighteni….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2961-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-28 |
| Published | 2018-09-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bayer Medical Care |
| Distribution | OH, TX, WV |
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
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.
Identifiers
| code_info | Serial Number: 4061630901 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2961-2018%22
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