Recall Z-2962-2018 ยท JAK System, X-Ray, Tomography, Computed
Bayer Medical Care, Inc.
Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
| Date | Jun 28, 2018 |
| Status | Terminated |
| 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. |
| 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 | 4 |
| Distribution | The devices were distributed to the following US states: OH, TX, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934206 | MAVIG ANGIO SHIELD MODELS 6290 & 6272 F. Walter Hanel GmbH, Oct 7, 1993 |