VSP Bolus

3D SYSTEMS, INC. · Model 1.0 · UDI-DI 00816847022613

IXI Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The 3D Systems VSP Bolus product is a device that will be placed on the skin of a patient as a radiotherapy accessory intended to help control the radiation dose received by the patient. VSP Bolus is generated using input from radiation therapy professionals and medical imaging data to produce a bolus that is specific to the patient being treated. The VSP Bolus product is verified and approved by the radiation therapy professional prior to use on the patient, and is intended for patients of all ages receiving radiotherapy treatment. VSP Bolus was evaluated using 6 MV photons but has not been assessed for use with protons, electrons, or at orthovoltage X-rays.

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.

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Data 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.