High FDA (Devices)·Z-1088-2015·Announced 2015-02-18

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.

What this means for you

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.
Category: Medical Device — Radiation Therapy Equipment
Hazard: structural-failure
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

Distributed in 9 states:

Same manufacturer · Elekta, Inc.

See all →

Severe
Fletcher CT/MR Shielded Applicator Set for Gynecological Brachytherapy Recalled
FDA (Devices) · 2026-07-15
Severe
Brachytherapy Applicator Advanced Gynecological Applicator Tip Detachment
FDA (Devices) · 2026-07-15
Severe
Elekta Geneva Brachytherapy Applicator Intrauterine Tube Detachment Risk
FDA (Devices) · 2026-07-15
High
MOSAIQ oncology software may fail to load adapted treatment plan
FDA (Devices) · 2026-06-17
High
Leksell Vantage Arc System locking mechanism may not secure properly
FDA (Devices) · 2026-05-06

Same hazard · structural failure