FDA Device recall Z-1088-2015
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licen…
- FDA Device
- Class II
- terminated
- Published 2015-02-18
On 2015-02-18 the FDA classified a Class II recall of Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licen… by Elekta, citing elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1088-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-07 |
| Published | 2015-02-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | AZ, CA, FL, KS, LA, MN, MO, NC, NY |
Product
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Reason
Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
Identifiers
| code_info | 153602, 153538, 153561, 153569, 153532, 153556, 153566, 153563, 153564, 153589, 153530, 153531, 153562, 153584, 153615,…153602, 153538, 153561, 153569, 153532, 153556, 153566, 153563, 153564, 153589, 153530, 153531, 153562, 153584, 153615, 153534, 153534, 153535, 153563, 153542, 153542, 153548, 153548, 153558, 153578, 153595, 153699, 153630, 153728, 153680, 153712. 153717, 153723, 153734, 153702, 153715, 153684, 153710, 153577, 153725, 153726, 153691, 153696, 153713, 153724, 153727 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1088-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.