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Terminated

Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01)

FDA Recall Z-0865-05 · Posted 2005-06-03

Recalling FirmPhilips Ultrasound, Inc.
Recall StatusTerminated
Product CodeDPW
Date Initiated2005-05-06
Date Terminated2008-05-21
Product Quantity1225 units

Reason for Recall

The acoustic display of Mechanical Index and Thermal Index is inaccurate - two transducers may exceed limits for acoustic intensity and MI.

Firm Action

On May 6, 2005 the firm mailed a letter, via return receipt requested, to customers. The letter advised of the problem, and provided instructions to create new low power presets. The letter also advised that software would be issued on/before November 2005.

Root Cause

Other

Distribution Pattern

The units were distributed worldwide. Domestic distribution included hospitals and medical centers.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002186VASCULAR ASSISTHuntleigh Healthcare, Inc. · 2001-05-02

Official Source

View FDA Recall →

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

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