Z-1134-2010

Leksell GammaPlan. Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta...

Name: Z-1134-2010 Leksell GammaPlan. Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta...
Creator: Elekta, Inc.
Published: 2008-10-23
License: https://open.fda.gov/license/

Elekta Limited / initiated 2008-10-23 / Terminated

FDA source

Elekta, Inc. began a recall of Leksell GammaPlan. Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. The Leksell GammaPlan is intended... on 2008-10-23. The reason FDA records is "Although the co-registration looks good during the verification step in the co-registration dialog, the obtain transformation may include an error that depends on the voxel sizes and acquisition parameters of the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1134-2010
Status: Terminated
Initiated: 2008-10-23
Posted: 2010-04-27
Terminated: 2010-12-14
Recalling firm: Elekta Limited
Product: Leksell GammaPlan. Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professional (Neurosurgeons, Radiation Therapists and Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.
Product code: IWB System, Radiation Therapy, Radionuclide
Reason for recall: Although the co-registration looks good during the verification step in the co-registration dialog, the obtain transformation may include an error that depends on the voxel sizes and acquisition parameters of the co-registered image studies.
FDA root cause: Other
Action: Important Notice A325 "Error in ImageMerge" dated November 21, 2008 was sent to affected customers and field service engineer as notification of the problem. The notice advises users not to use ImageMerge except if it is judged that the transformation error has no clinical significance. Information is provided in the release to help the user to make an informed decision on this issue. Field Change Order 200 084, "NTPS 8.3 SP1 for NTPS 8.0, 8.2 and 8.3" released January 28, 2009 was sent to affected customers as notification of the fix to this issue. This notice includes instructions to assist Elekta field service personnel in successfully upgrading the affected systems. Once the upgrade is in place, the issue will be corrected.
Quantity in commerce: 72 units
Distribution: Nationwide Distribution -- (AL, AZ, AR, CA, CO, FL, GA, HI, IL,KY, MA, MI, MS, NE, NV, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN TX and UT).
Product codes and lots: 4113, 4115, 4142, 4148, 4158, 4160, 4176, 4191, 4193, 4195, 4207, 4208, 4300, 4302, 4303, 4306, 4308, 4309, 4313, 4314, 4319, 4326, 4328, 4329, 4332, 4333, 4337, 4339, 4340, 4341, 4342, 4343, 4344, 4346, 4349, 4352, 4353, 4354, 4363, 4366, 4824, 4830,5000, 5003, 5019, 5023, 5026, 5034, 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, 6030, 6032, 6034, 6035, 6036, 6037, 6047 and 6049.

Product code IWB

K973441Class IILeksell GammaplanPatterson Consulting Group, Inc. / cleared 1998-04-01

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)