Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Reported: May 6, 2020 Initiated: March 30, 2020 #Z-1826-2020
Product Description
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Reason for Recall
A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.
Details
- Recalling Firm
- Elekta Inc
- Units Affected
- 25 units.
- Distribution
- US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT.
- Location
- Saint Charles, MO
Frequently Asked Questions
What product was recalled? ▼
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument. Recalled by Elekta Inc. Units affected: 25 units..
Why was this product recalled? ▼
A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2020. Severity: Moderate. Recall number: Z-1826-2020.
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