FDAFDA · Food and drugs·Recall number 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. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material Number 59880288
Published September 12, 2018 · Recall initiated: June 28, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bayer Medical Care, Inc.
- Distributor
- The devices were distributed to the following US states: OH, TX, and WV.
- Lot
- Serial Number: 4061630901
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.