Home / Recalls / Med Tec Inc / Z-1837-2019

Z-1837-2019 Class II Terminated

Recalled by Med Tec Inc — Orange City, IA

Recall Details

Product Type
Devices
Report Date
June 26, 2019
Initiation Date
April 15, 2019
Termination Date
October 5, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28 units

Product Description

CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to approximately 10¿ in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeter. The provider can correct the patient position for simulation and treatments by tilting the device.

Reason for Recall

There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.

Distribution Pattern

Worldwide distribution - US Nationwide distributed in the states of CA, HI, PA, KY, FL, WI, AK and countries of Australia, Canada, Italy, Netherlands, Switzerland, Peru.

Code Information

Part Numbers: a) CHS03, UDI 00841439112489 Lot Numbers: M602380, M680480, M847590, M870360 b) CHS04, UDI 00841439112496 Lot Numbers: M680530, M789100, M789110, M839690, M938500

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-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)