Home › DECIMAL, INC. › .decimal Proton Range Compensator
.decimal Proton Range Compensator
DECIMAL, INC. · Model 2.8 · UDI-DI 00851147007014
IXI
Prescription
1
510(k) clearances
38
Adverse events
6
Recalls
12
Facilities
Description
Custom manufactured solid Range Compensators for intensity modulation of external beam proton radiation therapy.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-08-15 | Elekta, Inc. | Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect. |
| 2013-05-01 | Elekta, Inc. | It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems |
| 2013-01-18 | Elekta, Inc. | If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions. |
| 2012-02-07 | Siemens Medical Solutions USA, Inc | This correction is being performed to update the safety knob of the Siemens brand mMLC (ModuLeaf) to conform to tie IEC 60601-1 safety standard. |
| 2011-02-03 | Xoft Inc. | Xoft Axxent Flexishield Mini product may may shed particles identified as tungsten, and may look like suspicious calcifications on follow up scans if the product was used during In |
| 2008-03-14 | Philips Medical Systems North America Co. Phillips | Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.