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Terminated

Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging.

FDA Recall Z-0358-06 · Posted 2006-01-06

Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeLNH
Date Initiated2005-12-09
Date Terminated2008-05-20
Product Quantity96

Reason for Recall

The Gyroscan NT MRI system has a computer software problem which results in images from one patient being placed into another patient's image record.

Firm Action

Product safety notification sent certified mail to each customer explaining the problem. A mandatory software upgrade to correct the problem will be installed starting the first quarter of 2006 and be completed by the third quarter of 2006.

Root Cause

Other

Distribution Pattern

96 units distributed to 92 U.S. Customers

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K940534GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE)Philips Medical Systems, Inc. · 1994-11-22

Official Source

View FDA Recall →

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

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