Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
FDA device recall Z-0885-2013 · posted 2013-02-26 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.
- Action taken
- Elekta sent an Important Field Safety Notice Field Safety Notice FCO Ref: 20001407029 "Important information for the safe and satisfactory operation of Apex" to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to obey all the applicable instructions, warning, and cautions in the user documentation for each piece of equipment. For questions regarding this recall call 770-300-9725.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- IXI
- Quantity affected
- 1
- Distribution
- Nationwide Distribution including TX
- Date initiated
- 2013-01-18
- Date posted
- 2013-02-26
- Date terminated
- 2014-05-08
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APEX (K111676) | Elekta Limited | 2011-09-30 |