Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Reported: February 18, 2015 Initiated: January 7, 2015 #Z-1088-2015
Product Description
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Reason for Recall
Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 46
- Distribution
- Worldwide Distribution - USA including 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.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.. Recalled by Elekta, Inc.. Units affected: 46.
Why was this product recalled? ▼
Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 18, 2015. Severity: Moderate. Recall number: Z-1088-2015.
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