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Extend Frame system
Elekta Instrument AB · Model 1024366 · UDI-DI 07340048304580
IWB
Prescription
10
510(k) clearances
214
Adverse events (4 deaths)
29
Recalls
10
Facilities
Description
DENTAL KIT ZHERMACK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-18 | Elekta, Inc. | Due to adapter not being properly aligned or locked in place. |
| 2023-11-30 | Xcision Medical Systems, LLC | Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected |
| 2019-07-03 | Xcision Medical Systems, LLC | One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output. |
| 2018-06-27 | Elekta Instrument AB | The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume. |
| 2017-05-23 | Elekta, Inc. | If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety for technicians doin |
| 2016-04-19 | Elekta, Inc. | The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame. |
| 2015-06-01 | Elekta, Inc. | Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2. |
| 2014-10-06 | Elekta, Inc. | Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame. |
| 2011-06-23 | Elekta, Inc. | There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical p |
| 2011-05-26 | Elekta, Inc. | Several of the LMR03 actuators with bronze drive nut have failed unexpectedly, creating a potential safety hazard for the operator and patient. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.