Elekta Recalls Laksell Gamma Knife Perfexion Units Due to Latch Defect
Elekta is recalling 181 Laksell Gamma Knife Perfexion units because latches may lock before being fully turned, resulting in a poorly locked frame.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a mechanical latch defect that could lead to a poorly locked frame, but the source text does not report any injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Elekta, Inc. is recalling 181 units of the Laksell Gamma Knife Perfexion medical device. The recall is due to a defect where the latches may be locked before they have been fully turned, which can result in a poorly locked frame.
The affected devices were distributed worldwide, including nationwide in the United States and in numerous other countries. The recall covers specific serial numbers listed in the agency's documentation.
Consumers and healthcare facilities should contact Elekta, Inc. for instructions on how to address the latch issue on their specific units.
The recalled product
- Product
- Laksell Gamma Knife Perfexion
- Manufacturer
- Elekta, Inc.
- Affected units
- 181
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial No. 6052
- 6144
- 6088
- 6122
- 6158
- 6005
- 6028
- 6097
- 6153
- 6064
- 6081
- 6103
- 6120
- 6143
- 6145
- 6213
- 6215
- 6076
- 6070
- 6136
Distribution
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