Elekta Inc: Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument

Is my product affected?

Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument

• UPC 7340048304887

Check against the official notice below — it lists the full affected range.

What happened

Elekta Inc. is recalling 25 units of the Leksell Vantage Stereotactic System's Instrument Carrier, which is part of the Leksell Vantage Arc used in neurological stereotaxic procedures. The recall was initiated after an internal check discovered that a locking piece on the Instrument Carrier does not provide adequate locking force to the Arc, creating a potential safety concern. The affected units were distributed nationwide across Massachusetts, New Hampshire, North Carolina, Utah, Ohio, Florida, Minnesota, New York, Louisiana, and Montana.

The recalled units can be identified by their serial numbers: SH00106, SH00120, SH00149, SH00160, SH00165, SH00110, SH00143, SH00150, SH00161, SH00166, SH00111, SH00144, SH00157, SH00162, SH00167, SH00112, SH00147, SH00158, SH00163, SH00168, SH00114, SH00148, SH00159, SH00164, and SH00178, with UDI 7340048304887. The source document does not specify what remedy affected consumers should pursue.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 from the source

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. Distribution: US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT. Quantity: 25 units. Lot/code info: Serial Numbers:SH00106, SH00120, SH00149, SH00160, SH00165, SH00110, SH00143, SH00150, SH00161, SH00166, SH00111, SH00144, SH00157, SH00162, SH00167, SH00112, SH00147, SH00158, SH00163, SH00168, SH00114, SH00148, SH00159, SH00164 and SH00178. UDI 7340048304887.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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