Z-2961-2018Class II

Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a...

Name: Z-2961-2018 Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a...
Creator: Bayer Medical Care, Inc.
Published: 2018-06-28
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2018-06-28 / Terminated / root cause: manufacturing process

FDA source

Bayer Medical Care, Inc. began a recall of 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... on 2018-06-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2961-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-28
Posted: 2018-08-31
Terminated: 2018-11-26
Recalling firm: Medrad, Inc.
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
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: On June 28, 2018, Urgent Medical Device Field Safety Corrective Action letters were distributed to customers. The letters informed the customers of the following: A Bayer Service Representative will be scheduling a service visit to replace the ceiling column assembly of your OCS system(s) at no cost to you.
Quantity in commerce: 1
Distribution: The devices were distributed to the following US states: OH, TX, and WV.
Product codes and lots: Serial Number: 4061630901

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2961-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2960-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-08-31
Z-2961-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-08-31
Z-2962-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-08-31

Product code JAK

K944983Class IIMedrad Counterpoise SystemMedrad, Inc. / cleared 1994-11-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)