Recall Z-0389-2022 ยท JAD System, Therapeutic, X-Ray
Xstrahl Limited
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
| Date | Aug 27, 2021 |
| Status | Terminated |
| Reason | Base plate may detach from the main body of the treatment applicator. |
| Root cause | Device Design |
| Action | The firm notified their consignees by email on 08/27/2021. The notice requested the following actions be taken: Xstrahl Limited are issuing the following inspection advice for all X150 specifical system users. 1. Prior to any clinical exposure the operator of the system should inspect the treatment applicator prior to inserting it into the treatment head of the X150. 2. As part of the daily assurance process the treatment applicators should be inspected. 3. If a treatment applicator is dropped it should be inspected by medical physics to ensure it is not damaged. 4. If the base plate is mis |
| Quantity | 120 applicators |
| Distribution | US and ALGERIA, AUSTRALIA, AUSTRIA, BULGARIA, CANADA, COSTA RICA, CROATIA, CYPRUS, DENMARK, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KAZAKHSTAN, LATVIA, MALTA, MEXICO, NEW ZEALAND, NORWAY, PANAMA, ROMANIA, RUSSIA, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UK, UKRAINE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962613 | DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM Gulmay Medical , Ltd., Sep 27, 1996 |