Home / Recalls / Med Tec Inc / Z-3082-2017

Z-3082-2017 Class II Terminated

Recalled by Med Tec Inc — Orange City, IA

Recall Details

Product Type
Devices
Report Date
September 6, 2017
Initiation Date
August 10, 2017
Termination Date
March 19, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
101 units

Product Description

CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment..

Reason for Recall

Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.

Distribution Pattern

Worldwide Distribution - US Distribution to the states of : MI, IL and TX., and to the countries of : Greece, Australia, Czech Republic, Hungary, Norway, Brazil, Italy, Switzerland ,UK, Austria, Slovenia, Croatia, Poland, Germany, Japan, France, Netherland, Sri Lanka, Pakistan, Bangladesh, and Israel

Code Information

Codes: M207190, M212200, M141830, M142280, M144220, M149540, M149550, M149560, M149580, M164440, M164470, M177290, M177330, M177340, M198070, M198100, M285840, M133130, M137690, M138630, M138640, M138650, M165550, M165560, M180420, M180430, M180440, M189150, M217660, M217670, M217680, M217710

Other recalls by Med Tec Inc

  • Z-2243-2020 Class II — Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: (May 12, 2020)
  • 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-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)