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Terminated

HD11XE Diagnostic Ultrasound System

FDA Recall Z-0987-2007 · Posted 2007-07-03

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeIYN
Date Initiated2007-04-25
Date Terminated2011-01-24
Product Quantity219 units in US and 347 units distributed internationally

Reason for Recall

Potential for erroneous measurements which may lead to incorrect diagnosis based upon the presence of an inaccurate, undetectable error in clinical measurement or calculation. If the user exits an imaging mode while Active Annotation is in use, the system can enter an undefined state where the image scale calibration may not match the scale of the on-screen measurements and graphics and possib

Firm Action

On 04/25/2007 firm sent letters dated 04/23/2007 to consignees informing them of the issue and that a new software release to correct the issue became available 04/19/2007. The firm's Field Service Representatives will contact consignees to install the new software at no charge to the consignee.

Root Cause

Other

Distribution Pattern

Worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043535HD11 DIAGNOSTIC ULTRASOUND SYSTEMPhilips Ultrasound, Inc. · 2005-01-06

Official Source

View FDA Recall →

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

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