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Terminated

Envisor, M2540 Diagnostic Ultrasound System

FDA Recall Z-0923-05 · Posted 2005-06-22

Recalling FirmPhilips Ultrasound, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2005-05-13
Date Terminated2008-05-09
Product Quantity194

Reason for Recall

A defect in the software allows incorrect measurement results to be entered into the system's built-in report.

Firm Action

On May 13, 2005 the firm mailed a letter to their customers advising of the problem and that a local representative will visit each site to perform a software upgrade.

Root Cause

Other

Distribution Pattern

Units were distributed nationwide to hospitals and medical centers and internationally.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K014191M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540Philips Medical Systems · 2002-01-07

Official Source

View FDA Recall →

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

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