Ion Beam Applications S.A.: Medical Device Recall in 2014 - (Recall #: Z-0836-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device.

Product Classification:

Class II

Date Initiated: November 7, 2014

Date Posted: December 31, 2014

Recall Number: Z-0836-2015

Event ID: 69781

Reason for Recall:

Two issues were identified: 1. In the release of adaPT insight v1.3.2., the kV/kV Single Source acquisition workflow was linked to a wrong geometrical calibration file, resulting in an alignment offset for this specific mode of acquisition. 2. A gantry collision incident required the IBA service team to verify the gantry alignment and protons I x-ray beams colinearity, du

Status: Terminated

Product Quantity: 1

Code Information:

PAT.109 (US), Treatment room 4

Distribution Pattern:

US Distribution in PA only.

Voluntary or Mandated:

Voluntary: Firm initiated