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Terminated

NT Intera Magnetic Resonance Image System

FDA Recall Z-1488-04 · Posted 2004-09-29

Recalling FirmPhilips Medical Systems Sales & Service Region No. America
Recall StatusTerminated
Product CodeKRP
Date Initiated2004-08-20
Date Terminated2006-02-09
Product Quantity156 devices

Reason for Recall

Potential for patient burn

Firm Action

On 8/20/04 the firm issued a letter, via certified return receipt. The letter warned of the potential for patient discomfort and burns. An addendum providing additional information regarding cable positioning was included with the letter.

Root Cause

Other

Distribution Pattern

Units distributed to medial facilities and hospitals throughout the U.S.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001796GYROSCAN INTERA (R7.5)Philips Medical Systems North America, Inc. · 2000-09-06

Official Source

View FDA Recall →

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

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