Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
Reported: March 20, 2013 Initiated: December 19, 2012 #Z-0931-2013
Product Description
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
Reason for Recall
The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 164
- Distribution
- Nationwide Distribution-DC, Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.. Recalled by Elekta, Inc.. Units affected: 164.
Why was this product recalled? ▼
The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 20, 2013. Severity: Moderate. Recall number: Z-0931-2013.
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