Elekta Apex add-on Micro MLC collimator recall for installation defect
Elekta, Inc. is recalling Apex add-on Micro MLC collimators for radiation therapy because incorrect installation may cause the touchguard inhibit to activate and restrict the view restrictions dialog box.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could impact safety interlocks (touchguard inhibit) and user interface visibility (view restrictions), representing a risk-of-harm product where specific injury has not yet been reported.
Plain-English summary
Elekta, Inc. is recalling one unit of the Apex add-on Micro MLC, a collimator used for radiation therapy. The recall is due to a defect where, if the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates and the view restrictions dialog box only shows the top 12 restrictions.
The product was distributed nationwide, including Texas. The specific code information for the affected unit is 152652.
Consumers and healthcare providers should contact Elekta, Inc. for further instructions regarding the recall and proper handling of the device.
The recalled product
- Product
- Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
- Manufacturer
- Elekta, Inc.
- Affected units
- 1
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 (1)
- 152652
Distribution
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