Elekta Precise Digital Accelerator Recall for Potential Securing Bolt Failure
Elekta is recalling 46 Precise Digital Accelerators because securing bolts for the gantry counter frame weight stack may fail.
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 structural component failure in a high-risk medical device used for radiation therapy. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Elekta, Inc. is recalling 46 units of the Precise Digital Accelerator. This medical device is intended for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
The recall was initiated because Elekta identified that a batch of securing bolts that fix the Gantry counter frame weight stack may fail. The affected units were distributed worldwide, including in the United States (AZ, CA, FL, KS, LA, MN, MO, NY, NC) and internationally to Austria, Bulgaria, Canada, China, Germany, Hungary, Italy, Malaysia, Malta, Netherlands, Norway, Russia, Spain, Sweden, Taiwan, and Ukraine.
Facilities using these devices should contact Elekta for further instructions regarding the recall and corrective actions.
The recalled product
- Product
- Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
- Manufacturer
- Elekta, Inc.
- Hazard
- Affected units
- 46
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)
- 153602
- 153538
- 153561
- 153569
- 153532
- 153556
- 153566
- 153563
- 153564
- 153589
- 153530
- 153531
- 153562
- 153584
- 153615
- 153534
- 153535
- 153542
- 153548
- 153558
Distribution
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