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Terminated

iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic)

FDA Recall Z-0422-2007 · Posted 2007-02-17

Recalling FirmPhilips Ultrasound, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2006-11-02
Date Terminated2009-07-14
Product Quantity619 domestic units, 706 international units

Reason for Recall

Acoustic output intensity may exceed maximum specified limits and the patient contact temperature may exceed 43 degree C (when the system is used with the S12-4 transducer in CW-mode)

Firm Action

On 11/2/06 the firm sent a letter dated October 31, 2006 to their customers. The letter explains the problem and states that new software is being released and will be available sometime in November. Customer service representatives will visit consignees to upgrade their units. The firm later determined they sent letters out to consignees that did not have affected units. Those consignees will be notified the week of 11/20/06 to disregard the previous letter.

Root Cause

Other

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030455BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEMPhilips Ultrasound, Inc. · 2003-03-13

Official Source

View FDA Recall →

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

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