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Terminated

Intinion 1.5 T MRI Scanner.

FDA Recall Z-0272-05 · Posted 2004-12-02

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2003-04-17
Date Terminated2008-10-29
Product Quantity93 units.

Reason for Recall

There is a potential for the patient to be exposed to cryogenic fluids (liquid air) dripping from the vent during a quench due to the location of the vent.

Firm Action

A Mandatory Service Letter, dated April 17, 2003, was sent to service technicians instructing the technicans to perform a mandatory safety modification.

Root Cause

Other

Distribution Pattern

Throughout the United States and to Denmark, England, China, Italy, Mexico, Israel, and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011296INFINION ENHANCEMENT PACKAGEPhilips Medical Systems (Cleveland), Inc. · 2001-07-19K003853INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100Philips Medical Systems (Cleveland), Inc. · 2001-02-13

Official Source

View FDA Recall →

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

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