All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage
FDA device recall Z-1065-2014 · posted 2014-03-07 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Customers are resetting the default values outside recommended factory settings.
- Action taken
- Elekta sent an Important Field Safety Notice dated May 2013 to all affected customers. The Notice identified the affected product, problem, clinical impact and actions to be taken. Customers were instructed to adhere to the instructions and advice given in manuals and system dialogues. For question contact your local Elekta office.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 472 units
- Distribution
- USA Nationwide Distribution in the states of: AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT
- Date initiated
- 2013-05-28
- Date posted
- 2014-03-07
- Date terminated
- 2021-09-15
- Location
- Atlanta, GA
Monitor recalls programmatically
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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 |