Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation t
FDA device recall Z-0931-2013 · posted 2013-03-10 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.
- Action taken
- Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated December 2012 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The IFSN informs the user in the TPS, to give the different volumes different structure names. After importing the patient data set from the TPS, make sure that the structure contours are correct. Users are requested to return the signed acknowledgement. Contact your local Elekta office for questions regarding this notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity 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, an
- Date initiated
- 2012-12-19
- Date posted
- 2013-03-10
- Date terminated
- 2021-07-14
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 (K051932) | Elekta, Inc. | 2005-08-12 |