Recall Z-2243-2020 ยท IYE Accelerator, Linear, Medical
Med Tec Inc
Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.
| Date | Jun 2, 2020 (initiated May 12, 2020) |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | On May 14, 2020, the firm sent a notification letter titled, "Urgent: Field Safety Notice Customer/Distributor Communication," to customers and distributors. The customer notification stated that a new warning will be added to the instruction manual at the next revision. The warning will state: To prevent extension from unintended disengagement, do not lift patient vertically to reposition while immobilized under a thermoplastic mask. Extensions that were further distributed, should be notified. An acknowledgement form should be returned to the firm by 05/29/2020. In addition, customers |
| Quantity | 171 units |
| 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, an |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933227 | UNI-FRAME HEAD IMMOBILIZATION SYSTEM Medtec, Inc., Jul 18, 1994 |