Recall Z-0957-2015 ยท MUJ System, Planning, Radiation Therapy Treatment
Brainlab AG
iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
| Date | Jan 15, 2015 (initiated Nov 19, 2014) |
| Status | Terminated |
| Reason | iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets. |
| Root cause | Software in the Use Environment |
| Action | Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 19, 2014, to all affected customers. The letter included instructions to: 1) If clinically not required, do not use multiple localized CT scans within one treatment plan (to avoid potentially incorrect Reference and Alignment Set assignments in the first place). 2) If you must use multiple localized CT scans, e.g. for recurrent treatment planning of the same patient, always guarantee that the latest (see note *) CT scan is defined as both Alignment Set and Reference Set during treatment planning. Brainlab will |
| Quantity | 1412 systems total |
| Distribution | Worldwide Distribution - USA including Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, N |
| FDA record | Open on fda.gov |