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Terminated

Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765

FDA Recall Z-2962-2018 · Posted None

Recalling FirmBayer Medical Care, Inc.
Recall StatusTerminated
Product CodeJAK
Date Initiated2018-06-28
Date Terminated2018-11-26
Product Quantity4

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.

Firm 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.

Root Cause

Equipment maintenance

Distribution Pattern

The devices were distributed to the following US states: OH, TX, and WV.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K934206MAVIG ANGIO SHIELD MODELS 6290 & 6272F. Walter Hanel GmbH · 1993-10-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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