Recall Z-2243-2020— Med Tec Inc
Class II · Terminated
Class II FDA medical device recall by Med Tec Inc, initiated 2020-05-12, terminated 2021-03-25. It names one FDA 510(k) clearance: K933227. Product: Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.. 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..
- Recalling firm
- Med Tec Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-12
- Terminated
- 2021-03-25
- Firm location
- Orange City, IA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.