Z-2138-2018Class II

12C

Name: Z-2138-2018 12C
Creator: Ion Beam Applications S.A.
Published: 2016-09-16
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2016-09-16 / Terminated

FDA source

Ion Beam Applications S.A. began a recall of 12C on 2016-09-16. FDA classified it as Class II and gives the reason as "IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2138-2018
Classification: Class II
Status: Terminated
Initiated: 2016-09-16
Posted: 2018-06-08
Terminated: 2019-02-08
Recalling firm: Ion Beam Applications S.A.
Product: 12C
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.
FDA root cause: Finished device change control
Action: IBA mailed an Urgent Field Safety Notice to affected customers on 09/16/2016 to notify them of the risks associated with the use of this device to prevent serious injury/death. Customers were asked not to make any unauthorized modification to the IBA System or IBA accessories unless approved in writing or in advance by IBA. IBA will be updating their manuals to include these warnings.
Quantity in commerce: S0 Units
Distribution: Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.
Product codes and lots: Code/Serial Numbers: PAT.000, PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126, SBF.101

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2138-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2138-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-08
Z-2139-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-08

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)