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Terminated

HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).

FDA Recall Z-0178-05 · Posted 2004-11-05

Recalling FirmPhilips Ultrasound, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2004-09-10
Date Terminated2006-02-09
Product Quantity333 domestic units, 29 demos, 704 international units

Reason for Recall

Potential for device to cause burning of the skin.

Firm Action

On 9/6/04 the firm sent a certified return receipt letter to customers advising of the issue and informing that a service representative will visit to install new software to reduce thermal output.

Root Cause

Other

Distribution Pattern

Units were distributed to medial facilities, hospitals, and veterinarians worldwide. Countries include Africa, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Domican Republic, Ecuador, France, Germany, Greece, Guam, Guatemala, Hungary, India, Israel, Italy, Jordan, Kuwait, Martinique, Mexico, Netherlands, New Zealand, Norway, Phlippines, Portugal, Puerto Rico, Peru, Santa Domingo, Saudia Arabia, Selangor, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, Zenica

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002185SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEMMedison America, Inc. · 2000-08-01

Official Source

View FDA Recall →

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

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