Home / Recalls / Med Tec Inc / Z-2243-2020

Z-2243-2020 Class II Terminated

Recalled by Med Tec Inc — Orange City, IA

FDA device recall Z-2243-2020 was initiated by Med Tec Inc on May 12, 2020 and is designated Class II. 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 no… The recall status is terminated (terminated March 25, 2021). Affected quantity: 171 units.

Recall Details

Product Type
Devices
Report Date
June 10, 2020
Initiation Date
May 12, 2020
Termination Date
March 25, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
171 units

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.

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.

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

Other recalls by Med Tec Inc

  • Z-1837-2019 Class II — CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 (April 15, 2019)
  • Z-0671-2018 Class II — Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4. (November 8, 2017)
  • Z-3082-2017 Class II — CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standar (August 10, 2017)
  • Z-3083-2017 Class II — CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Se (August 10, 2017)
  • Z-1992-2016 Class II — Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), (March 31, 2016)
  • Z-2763-2015 Class II — CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged (August 19, 2015)
  • Z-0990-2015 Class II — Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs (December 11, 2014)
  • Z-0989-2015 Class II — Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-ster (December 11, 2014)

FDA data resources