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U.S. Department of Health and Human Services

Class 2 Device Recall Type S Extension for use with Varian, CIVCO

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  Class 2 Device Recall Type S Extension for use with Varian, CIVCO see related information
Date Initiated by Firm May 12, 2020
Date Posted June 02, 2020
Recall Status1 Terminated 3 on March 25, 2021
Recall Number Z-2243-2020
Recall Event ID 85654
510(K)Number K933227  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.
Code Information Part Number: MTCFHNV UDI: 00841439104156 Lot Numbers: M027990; M505880; M847500; M166160; M505890; M858580; M198170; M505900; M858590; M241650; M505910; M869030; M249180; M511240; M885500; M257630; M530920; M918000; M278760; M541350; M919980; M282330; M553300; M919990; M283380; M553720; M928400; M293670; M553740; M928410; M300750; M596220; M934260; M303010; M596230; M936110; M314410; M616690; M942400; M321880; M616700; M942510; M323560; M649630; M944110; M326580; M649670; M951030; M333420; M649770; M964730; M350700; M715520; M979830; M356130; M715540; M987460; M362290; M743010; M995860; M365740; M767820; M369700; M774760; M371990; M782390; M418080; M796350; M436620; M796360; M439700; M802120; M442410; M805650; M446460; M809050; M448260; M809060; M457870; M820300; M457880; M829290; M462640; M834400; M493710; M844990; M495030; M845000  
Recalling Firm/
Manufacturer		 Med Tec Inc
1401 8th St Se
Orange City IA 51041-7463
For Additional Information Contact
712-737-8688
Manufacturer Reason
for Recall		 Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk associated with the disengagement of the extension could be a patient fall if the patient is not supported by clinical staff.
FDA Determined
Cause 2		 Component design/selection
Action On May 14, 2020, the firm sent a notification letter titled, "Urgent: Field Safety Notice Customer/Distributor Communication," to customers and distributors. The customer notification stated that a new warning will be added to the instruction manual at the next revision. The warning will state: To prevent extension from unintended disengagement, do not lift patient vertically to reposition while immobilized under a thermoplastic mask. Extensions that were further distributed, should be notified. An acknowledgement form should be returned to the firm by 05/29/2020. In addition, customers need to complete a form which states that they have been informed of the field safety notice involving the Type-S Extension, Varian Style and that notice has been read and understood by all operators of the device. In addition, the customers need to review their inventory for the affected products. Customers need to identify whether they no longer have the Type-S Extension, Varian Style or currently have the Type-S Extension, Varian Style. Customers need to acknowledge that have read and understand the Field Safety Notification and notified users of the device to not lift the patient vertically to reposition while immobilized under a thermoplastic mask. Customers need to identify the quantity of the devices at the facility, as well as, lot numbers and serial numbers. The forms should be returned by FAX or email to: Attention: CIVCO Radiotherapy Type-S Extension North American Customer use: Order@CivcoRT.com or 1-800-842-8688 International Customers use: DistorderCivcoRT.com or 1-712-737-8688 Customers can contact the firm's sales representative for additional assistance by calling the firm between 8:00AM and 5:00PM CST. The firm's distributor notification letters stated that the firm has initiated a field action due to the potential for disengagement of the Type-S Extension, Varian Style during patient setup and/or repositioning. The firm has iden
Quantity in Commerce 171 units
Distribution Worldwide distribution - US Nationwide distribution including in the states of WI, TX, AZ, FL, NE, TN, MA, FL, GA, IN, OR, PA, IL, LA, NH, MS, MI, OH, MN, VA, IA, CA, NC, SC, AK, UT, WA, MO, MT, KS, and WV. The countries of Africa, Colombia, Saudi Arabia, Costa Rica, South Korea, Hungary, Spain, and Italy.
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 = IYE and Original Applicant = MEDTEC, INC.
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