FDA recall Z-2243-2020

Product

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.

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.

Key facts

Status

Terminated

Initiation date

2020-05-12

Report date

2020-06-10

Termination date

2021-03-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orange City, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2243-2020