Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a l
FDA device recall Z-0305-2012 · posted 2011-11-29 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- If "Confirm" or "Unconfirm" settings are clicked during the "Terminated Checking" phase of treatment delivery, Desktop Pro cancels the loaded beam and sets the Beam MUs to zero. Desktop Pro then sends the delivered MUs to MOSAIQ a a zero value.
- Action taken
- Elekta sent an IMPORTANT NOTICE letter dated March 9, 2011 to affected customers. The notice identified the product, the problem, and the corrective action to be taken by the customer. The notice advise all customers to follow any instructions or recommendations covered in the Notice. For questions call +44(0)1293 654200.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 56
- Distribution
- Nationwide Distribution (USA) including the states of: AZ, CA, GA, IL, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, TN, VA, WI and Puerto Rico
- Date initiated
- 2011-03-09
- Date posted
- 2011-11-29
- Date terminated
- 2012-08-09
- Location
- Norcross, 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 |