Xstrahl Limited Recall 88545
Description: Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Xstrahl Limited Recall 88545 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0389-2022 |
| Event ID | 88545 |
| Event Description | Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system |
| Product Type | Devices |
| 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 |
| Quantity | 120 applicators |
| Recall Reason | Base plate may detach from the main body of the treatment applicator. |
| Device Classification | 20211222 |
| Device Code Info | GM0072, GM0077, GM0086, GM0117, GM0131, GM0158, GM0184, GM0189, GM0275, GM0307, GM0338, GM0379, GM0414, GM0469, GM0506 |
| Center Classification Date | 20211216 |
| Recall Initiation Date | 20210827 |
| Recalling Firm | Xstrahl Limited |
| Initial Notification | |
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