Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norcross, GA 30092. Inten
FDA device recall Z-1405-2010 · posted 2010-04-16 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- It is possible that two (or more) CT reference data sets are necessary for one patient, for example, if you have to scan a patient during breath hold and then again during free breathing.
- Action taken
- Elekta, Inc. issued an "Important Notice" dated December 12, 2008. Customers were informed of the affected device and instructed on proper steps until an update is provided. For further information, contact Elekta, Inc. at 1-770-300-9725.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 76 units
- Distribution
- Nationwide Distribution -- AL, AZ, CO, CT, FL, GA, ID, KS, KY, MA, MI, MN, MS, NE, NY, OH, OK, OR, PA, TN, TX, VA, WA and WV.
- Date initiated
- 2008-12-12
- Date posted
- 2010-04-16
- Date terminated
- 2010-12-28
- Location
- Norcross, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 (K051932) | Elekta, Inc. | 2005-08-12 |