Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatments in stereotactic radiation th
FDA device recall Z-1223-2011 · posted 2011-02-14 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Investigation found that if a user accidentally selects the wrong image/tube position images can be displayed flipped.
- Action taken
- Product bulletin Leksell GammaPlan - "Leksell GammaPlan version 5.34" (dated October 2005) was sent to affected Customers as notification of the problem. Field Change Order FCO-DCO-05-0006 (dated November 22, 2005) and Technical Notes Leksell GammaPlan Leksell SurgiPlan Important Notice - "Potential issue using flipped angiographic images" (dated October 2005) was sent to Elekta Service Engineers as notification of the problem. The letters described the issue and the FCO asked the Service Engineers to confirm their receipt of the documentation. The Technical Notes also discussed image visualization requirements and listed recommendations.
- Root cause
- Other
- Status
- Terminated
- Product code
- IWB
- Quantity affected
- 272 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2005-10-01
- Date posted
- 2011-02-14
- Date terminated
- 2011-03-02
- Location
- Norcross, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEKSELL GAMMAPLAN (K973441) | Patterson Consulting Group, Inc. | 1998-04-01 |