Z-2622-2011

Interplant Radiation Treatment Planning System, Interplant Release 3.4.0 Used when planning and performing...

Name: Z-2622-2011 Interplant Radiation Treatment Planning System, Interplant Release 3.4.0 Used when planning and performing...
Creator: Computerized Medical Systems Inc
Published: 2008-12-01
License: https://open.fda.gov/license/

Elekta Limited / initiated 2008-12-01 / Terminated / root cause: software

FDA source

Computerized Medical Systems Inc began a recall of Interplant Radiation Treatment Planning System, Interplant Release 3.4.0 Used when planning and performing prostate brachytherapy implant procedure. It... on 2008-12-01. The reason FDA records is "Interplant Software: If the trajectory needle with a non-zero retraction is adjusted in any of the planning views (Transverse, 3D) and the program is closed and reopened, the Needle Definitions page in the Dose Plan...". 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-2622-2011
Status: Terminated
Initiated: 2008-12-01
Posted: 2011-06-23
Terminated: 2013-04-04
Recalling firm: Elekta Limited
Product: Interplant Radiation Treatment Planning System, Interplant Release 3.4.0 Used when planning and performing prostate brachytherapy implant procedure. It provides ultrasound probe alignment and radioactive seed implantation.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Interplant Software: If the trajectory needle with a non-zero retraction is adjusted in any of the planning views (Transverse, 3D) and the program is closed and reopened, the Needle Definitions page in the Dose Plan Summary (Plan View) displays the needle with a 0.00 retraction even when the needle is displayed correctly in the planning view. If the Eliminate Leading Spacers function is applied t
Root cause tag: software
FDA root cause: Software design
Action: Computerized Medical Systems, Inc. sent a "CUSTOMER ADVISORY" letter dated December 1, 2008, to all affected customers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to discontinue use of the product. There is no workaround at this time. This issue was resolved in Interplant Release 3.4.1 software. All possibly affected users have been shipped the Interplant Release 3.4.1 software in May 2010. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.
Quantity in commerce: 41
Distribution: Worldwide Distribution -- USA (nationwide) including states of: CA, KS, KY, MA, MD, ME, MO, NC, NE, NY, OH, PA, TX and VA and countries of: Australia, Brazil, Chile, China, Germany and Japan.
Product codes and lots: Interplant Release 3.4.0

Product code MUJ

K982696Class IIInterplantBurdette Medical Systems, Inc. / cleared 1999-04-01

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)