PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 10, 2020 Initiated: May 12, 2020 #Z-2243-2020

Product Description

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

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.

Details

Recalling Firm
Med Tec Inc
Units 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, and WV. The countries of Africa, Colombia, Saudi Arabia, Costa Rica, South Korea, Hungary, Spain, and Italy.
Location
Orange City, IA

Frequently Asked Questions

What product was recalled?
Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.. Recalled by Med Tec Inc. Units affected: 171 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 10, 2020. Severity: Moderate. Recall number: Z-2243-2020.