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Terminated

Gyroscan NT-Intera

FDA Recall Z-1228-03 · Posted 2003-09-12

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeLNH
Date Initiated2002-11-21
Date Terminated2005-01-13

Reason for Recall

Patient burns from cables near or in contact with the patient during use

Firm Action

On 11/21/02, the firm provided Field Change Order (FCO) 781 00006 to their field employees. This FCO instructed the field employees to visit the consignees and provide them with the addendums to the Instruction For Use Manual.

Root Cause

Other

Distribution Pattern

The firm distributed units to hospitals and medical centers throughout the U.S.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932645PHILIPS GYROSCAN TN 15Philips Medical Systems, Inc. · 1993-12-13

Official Source

View FDA Recall →

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

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