Device product
Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.
Z-2243-2020
Product summary
- Firm
- Med Tec Inc
- Event
- Event 85654
- Status
- Terminated
- Classification
- Class II
- Quantity
- 171 units
- Official record key
device-enforcement:Z-2243-2020
Official wording
Reason: 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.
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
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.