Z-0836-2015Class II

adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon...

Name: Z-0836-2015 adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon...
Creator: Ion Beam Applications S.A.
Published: 2014-11-07
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2014-11-07 / Terminated / root cause: software

FDA source

Ion Beam Applications S.A. began a recall of 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... on 2014-11-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0836-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-07
Posted: 2014-12-19
Terminated: 2015-06-29
Recalling firm: Ion Beam Applications S.A.
Product: 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 code: LHN System, Radiation Therapy, Charged-Particle, Medical
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
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: The firm, IBA, sent a " User Notice" dated November 7, 2014, to the sole affected site-UPHS Customer. The notice describes the product, problem and actions to be taken. The customer was instructed that the KV/kV source acquisition mode has been disabled and shall not be used for patient alignment until system is officially confirmed to be back within tolerances. IBA will change the kV/kV Single Source acquisition workflow configuration file to be linked to the correct geometrical calibration file and will update the kV/kV Single Source calibration file that includes the colinearity parameters, with the correct values. If you need assistance, contact the IBA Site Staff or the Operations manager at +32 10 475 997 or email: [email protected].
Quantity in commerce: 1
Distribution: US Distribution in PA only.
Product codes and lots: PAT.109 (US), Treatment room 4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0836-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0836-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-19

Product code LHN

K132847Class III2cIon Beam Applications S.A. / cleared 2013-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)