Leksell GammaPlan. Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument
FDA device recall Z-1134-2010 · posted 2010-04-27 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IWB
- Quantity affected
- 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).
- Date initiated
- 2008-10-23
- Date posted
- 2010-04-27
- Date terminated
- 2010-12-14
- Location
- Norcross, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEKSELL GAMMAPLAN (K973441) | Patterson Consulting Group, Inc. | 1998-04-01 |