FDA Medical Device Recalls (openFDA)
Bayer Medical Care, Inc.: Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
- Recall number
- Z-2962-2018
- Recalling firm
- Bayer Medical Care, Inc.
- Product
- Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
- Status
- Terminated
- Initiated
- 2018-06-28
- Posted
- not on file
- Terminated
- 2018-11-26
- 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.
- Lot, serial or model codes
- Serial Numbers: 917/21956, 516/21035, 817/21916, 817/21910
- 510(k) numbers
- ["K934206"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 2520313
- Firm city
- Indianola
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28