Elekta Medical Linear Accelerator Recall for Loose Drive Gear Joint
Elekta is recalling 553 Medical Linear 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. The hazard involves mechanical failure (fatigue failure of bolts) in a medical device, which poses a risk of harm, but the source text does not report specific injuries or hospitalizations, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Elekta, Inc. is recalling 553 units of the Medical Linear Accelerator. The recall is due to instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose. This looseness has led to fatigue failure of some of the securing bolts.
The affected devices were distributed in 21 U.S. states and numerous international locations, including Argentina, Australia, Brazil, China, France, Germany, India, Japan, and the United Kingdom. The specific distribution pattern includes AL, AZ, CA, FL, GA, KY, MI, MN, MO, NE, NJ, NY, NC, OH, OK, PA, SC, TX, WA, WV, and the listed foreign countries.
Hospitals and healthcare facilities using these devices should contact Elekta, Inc. for instructions on how to address the defect. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Medical Linear Accelerator
- Manufacturer
- Elekta, Inc.
- Affected units
- 553
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)
- 105639
- 105652
- 105608
- 151187
- 151401
- 105792
- 105570
- 151577
- 151563
- 151562
- 151444
- 151347
- 151746
- 105557
- 151434
- 105801
- 151702
- 151052
- 151384
- 151661
Distribution
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