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Terminated

Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887

FDA Recall Z-2442-2020 · Posted None

Recalling FirmElekta Instrument AB
Recall StatusTerminated
Product CodeHAW
Date Initiated2020-06-10
Date Terminated2024-08-27
Product Quantity51 devices

Reason for Recall

The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.

Firm Action

The firm notified their consignees on 06/10/2020 by email. The notice explained the problem and provided directions on the removal of the spring. The firm offered assistance with the removal and provided the following contact: [email protected].

Root Cause

Device Design

Distribution Pattern

MA, IL, NH, NC, UT, OH, FL, MN, TX, NY, LA, AZ, MT, WV, Austria, Croatia, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lithuania, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K171123Leksell Vantage Stereotactic SystemElekta Instrument AB · 2017-09-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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