Date Initiated by Firm | June 28, 2018 |
Create Date | August 31, 2018 |
Recall Status1 |
Terminated 3 on November 26, 2018 |
Recall Number | Z-2960-2018 |
Recall Event ID |
80727 |
510(K)Number | K944983 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253 |
Code Information |
Serial Numbers: 11051103902, 305746202 |
Recalling Firm/ Manufacturer |
Bayer Medical Care, Inc. 1 Bayer Dr Indianola PA 15051-9702
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For Additional Information Contact | 412-406-3305 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 | 2 |
Distribution | The devices were distributed to the following US states: OH, TX, and WV. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JAK
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