Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioni

FDA device recall Z-2243-2020 · posted 2020-06-02 · Terminated

Recall details

Recalling firm

Med Tec Inc

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.

Action taken

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

Root cause

Component design/selection

Status

Terminated

Product code

IYE

Quantity affected

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, a

Date initiated

2020-05-12

Date posted

2020-06-02

Date terminated

2021-03-25

Location

Orange City, IA

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