Stealth Station Cranial Application v.4.5

Date posted by the FDA

April 16, 2005

Status

Terminated

Filed by

Medtronic Surgical Navigation Technologies, Inc

Product

Stealth Station Cranial Application v.4.5

Reason

The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient.

Distribution pattern

Domestic distribution: FL, CO, AZ, TX, AR, MT, OK, IL, PA, NY, LA, WI, NC, ND, CA, GA, AL, OR, WY, WA, OH, NV. Foreign distribution: Belgium, Czech Republic, China (Malaysia). No military or VA facilites.

Quantity

53 systems with software version 4.5

Codes and lots

Catalog Numbers: 960-201 and 9730888. Cranial Application software v.4.5.

Recall started

Jan. 28, 2005

Device type

Neurological Stereotaxic Instrument

Root cause (FDA)

Other

What the company told customers

Customers were sent notification letters dated 01/28/05 and 02/02/05.

Recall number

Z-0711-05

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0711-05. The agency record governs; check it and the company before acting.