ELEKTA SOLUTIONS AB Recall 88771
Description: Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
ELEKTA SOLUTIONS AB Recall 88771 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0115-2022 |
| Event ID | 88771 |
| Event Description | Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093. |
| Product Type | Devices |
| Distribution | Distribution was to ND and NC. There was no military/government distribution. |
| Quantity | 2 in the U.S. |
| Recall Reason | There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter. |
| Device Classification | 20211020 |
| Device Code Info | Elekta Harmony Pro, Serial #441009, UDI (01) 05060191071604; Elekta Infinity, Serial #156645, UDI (01) 05060191071543; and Elekta Versa HD, Serial #156646, #156477, and #156648, UDI (01) 05060191071574 |
| Center Classification Date | 20211014 |
| Recall Initiation Date | 20210928 |
| Recalling Firm | ELEKTA SOLUTIONS AB |
| Initial Notification | Letter |
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