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U.S. Department of Health and Human Services

Class 2 Device Recall CIVCO ProLok Platform, REF MTSBRT002

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  Class 2 Device Recall CIVCO ProLok Platform, REF MTSBRT002 see related information
Date Initiated by Firm December 30, 2010
Date Posted August 15, 2011
Recall Status1 Terminated 3 on June 28, 2013
Recall Number Z-3019-2011
Recall Event ID 57543
510(K)Number K973842  
Product Classification Table, radiographic, stationary top - Product Code IXQ
Product CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa


Product Usage: The recalled product is intended to support and aid in positioning a patient during radiologic and other medical procedures.
Code Information M074130, M092920, M115600, M143230, M165570, M188350, M191650, M207130, M208340, M213570, M218300, M230730, M248840, M248850 and M268010
Recalling Firm/
Manufacturer		 Civco Medical Instruments Inc
102 1st St S
Kalona IA 52247-9589
For Additional Information Contact James Leong
319-656-4447
Manufacturer Reason
for Recall		 Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action CIVCO issued a "FIELD SAFETY NOTIFICATION" letter dated 12/20/2010 beginning 12/30/2010, via FedEx or UPS to distributors and customers. The notification identifies the affected device, problem, and field safety corrective action. The letter states that if customers have more than one system purchased from different time periods that they should examine their systems and assess if there is any mismatch. The recalling firm will rework the system to correct the difference and send it back to the customer. To take advantage of this correction customers are advised to contact the recalling firm within thirty days of receiving the safety notification. The letter includes a response form to be completed and returned as per instructions, to indicate that the notice has been read and understood by all operators of the equipment. The letter to distributors requested that a copy of the notification letter be forward to all customers who have received this component. For assistance contact your CIVCO insides sales representative by calling CIVCO Medical Solutions, Radiation Oncology, at 800-842-8688.
Quantity in Commerce 20 platforms
Distribution Worldwide Distribution - USA ( nationwide) including the state of PA. and countries of: Canada, China, England, Israel, Italy, Japan, Korea, The Netherlands, Russia, Spain, Sweden, Switzerland and Turkey.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = IXQ and Original Applicant = MEDTEC, INC.
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