Elekta Inc Recall 88676
Description: Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Elekta Inc Recall 88676 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2563-2021 |
| Event ID | 88676 |
| Event Description | Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of PA, MI, WI, NY, TN, NJ, IA, TX and the countries of United Kingdom, Turkey, Switzerland, Sweden, Spain, Netherlands, Korea, Thailand, Japan, Italy, Hong Kong, Germany, France, Denmark, China, Canada, Belgium, Bahrain, Australia. |
| Quantity | 214 units |
| Recall Reason | Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set. |
| Device Classification | 20211006 |
| Device Code Info | Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10; UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002190(10) 5.40.01, (01)00858164002190(10) 5.40.02, (01)00858164002268(10) 5.51.10 |
| Center Classification Date | 20210924 |
| Recall Initiation Date | 20210914 |
| Recalling Firm | Elekta Inc |
| Initial Notification | |
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