—#88849

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.

FDA product code: IWB — System, Radiation Therapy, Radionuclide
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K973441
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, Georgia 30092-3011

Distribution

Distribution pattern: 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).

Timeline

Recall initiated: 2008-10-23
Posted by FDA: 2010-04-27
Terminated: 2010-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88849. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.