Orange City, IA, United States
Med Tec Inc recalls
3 recalls recorded since 2018, most recently on 12 May 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 12 May 2020
- Terminated
- 25 March 2021
- 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.
- 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,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2243-2020
- Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.
Terminated Class II Medical devices
- Recall started
- 15 April 2019
- Terminated
- 5 October 2020
- Reason
- There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1837-2019
- 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 permanen
Terminated Class II Medical devices
- Recall started
- 8 November 2017
- Terminated
- 21 August 2020
- Reason
- When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to not update with the pedestal location and buffers the pedestal movement history.
- Distribution
- US Distribution to Iowa and South Dakota. Shipped internationally to the Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0671-2018
- Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6X
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.