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U.S. Department of Health and Human Services

Class 2 Device Recall CIVCO Arm Support

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  Class 2 Device Recall CIVCO Arm Support see related information
Date Initiated by Firm August 10, 2017
Create Date August 29, 2017
Recall Status1 Terminated 3 on March 19, 2024
Recall Number Z-3083-2017
Recall Event ID 77874
Product Classification Cradle, patient, radiologic - Product Code KXH
Product CIVCO Arm Support, REF 106047, distributed as:
(a) Rigid Arm Support, Large, Set, Red (PN: 106047)
(b) PB2-BDLRL (PN: 109040)
(c) Rigid Adj. Arm Support, Large, Set (PN: 106048)
(d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522)

The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.
Code Information Codes: M181690, M194500, M203470, M213330, M216050, M142180, M143110, M149600, 0154710, M158550, M165330, M16900, M169330, M142230, M149650, M236810
Recalling Firm/
Manufacturer		 Med Tec Inc
PO Box 320
1401 8th St SE
Orange City IA 51041-7463
For Additional Information Contact Jennifer Blauvelt
319-248-6537
Manufacturer Reason
for Recall		 Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.
FDA Determined
Cause 2		 Other
Action CIVCO sent an Urgent: Field Action Notice- Customer Communication letter dated July 20th, 2017. The field action notification letter was sent on August 10, 2017, by email requesting the consignee review their inventory and contact their sales representative for product replacement. Enclosed please find a notification letter which is required to be sent to all customers who received this product. Please contact your Insides Sales Representative concerning replacement instructions if you have any questions. You may reach your representative by calling CIVCO Radiotherapy, at 712-737-8688 between 8:00AM and 5:00PM CST. For further question, please call (319) 248-6537.
Quantity in Commerce 30 units
Distribution Worldwide Distribution - US Distribution to the states of : MI, IL and TX., and to the countries of : Greece, Australia, Czech Republic, Hungary, Norway, Brazil, Italy, Switzerland ,UK, Austria, Slovenia, Croatia, Poland, Germany, Japan, France, Netherland, Sri Lanka, Pakistan, Bangladesh, and Israel
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.
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