iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assi
FDA device recall Z-1807-2014 · posted 2014-06-17 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- A bug in the software prevents the iGUIDE software from logging off.
- Action taken
- Elekta sent an Important Field Safety Notice 618 01 303 024 dated May 29, 2014 to affected customers. The letter identified the affected product, problem, potential clinical impact and actions to be taken. It also gives a recommendation how the risk can be mitigated - Users should only use the iGUIDE software when the key is in the on position and the Position Guard is active. Users are advised to restart the workstation if any error occurs to ensure the software is running properly. The notice also advises the customer that a patch will be released that corrects the behavior of the iGUIDE software. This solution will be implemented on all affected products when available. For questions contact your local Elekta office.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 224
- Distribution
- Worldwide Distribution - USA (nationwide) in the states of AZ, CA, CT, HI, IL, IA, KY, MD, MA, MI, MO, NH, NJ, NC, ND, OH, OK, OR, PA, TX, VA, WA, WI, and the countries of Algeria, Australia, Austria,
- Date initiated
- 2014-05-29
- Date posted
- 2014-06-17
- Date terminated
- 2017-09-29
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IGUIDE SYSTEM (K072079) | Medical Intelligence Medizintechnik-GmbH-An Elekta | 2007-08-14 |