Elekta Precise Digital Accelerator Recall Due to Loose Drive Gear Joint
Elekta is recalling 110 Precise Digital Accelerators because a loose joint between the drive gear and gantry base drive wheel can lead to fatigue failure of securing bolts.
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 is classified as FDA Class II, and the source describes a mechanical defect (fatigue failure of bolts) in a high-risk medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Elekta, Inc. is recalling 110 units of the Precise Digital Accelerator, a medical device used for the delivery of radiation to defined target volumes. The recall is due to a mechanical defect where the joint between the drive gear and the gantry base drive wheel has become loose in a small number of hospital instances. This looseness has led to fatigue failure of some of the securing bolts.
The affected devices were distributed nationwide, including in Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Iowa, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, Nevada, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Virginia, South Carolina, Tennessee, Texas, Washington, West Virginia, Wisconsin, and Puerto Rico. The recall covers specific serial numbers listed in the agency's structured data.
Hospitals and healthcare facilities using these devices should contact Elekta, Inc. for instructions on how to address the defect. The source text does not report any specific injuries or illnesses associated with this mechanical failure.
The recalled product
- Product
- Precise Digital Accelerator Delivery of radiation to defined target volumes
- Manufacturer
- Elekta, Inc.
- Affected units
- 110
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)
- 151587
- 105932
- 151574
- 151363
- 151076
- 151110
- 151369
- 151504
- 105941
- 151418
- 151674
- 151566
- 151259
- 151636
- 151568
- 151390
- 151258
- 151584
- 151391
- 151317
Distribution
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