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U.S. Department of Health and Human Services

Class 2 Device Recall Portegra 2 Overhead Counterpoise System

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 Class 2 Device Recall Portegra 2 Overhead Counterpoise Systemsee related information
Date Initiated by FirmJune 28, 2018
Create DateAugust 31, 2018
Recall Status1 Terminated 3 on November 26, 2018
Recall NumberZ-2962-2018
Recall Event ID 80727
510(K)NumberK934206 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductOverhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
Code Information Serial Numbers: 917/21956, 516/21035, 817/21916, 817/21910
Recalling Firm/
Manufacturer		 Bayer Medical Care, Inc.
1 Bayer Dr
Indianola PA 15051-9702
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
ActionOn 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 Commerce4
DistributionThe devices were distributed to the following US states: OH, TX, and WV.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = JAK
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