Date Initiated by Firm |
April 17, 2003 |
Date Posted |
December 02, 2004 |
Recall Status1 |
Terminated 3 on October 29, 2008 |
Recall Number |
Z-0272-05 |
Recall Event ID |
30416 |
510(K)Number |
K003853 K011296 software:K024066
|
Product Classification |
System, Nuclear Magnetic Resonance Imaging - Product Code LNH
|
Product |
Intinion 1.5 T MRI Scanner. |
Code Information |
Serial Numbers ZA101-ZA188, ZA190-192, ZA195, ZA200, ZA201. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Road Cleveland OH 44143-2131
|
For Additional Information Contact |
Michael J. Hayes 440-483-3521
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Other |
Action |
A Mandatory Service Letter, dated April 17, 2003, was sent to service technicians instructing the technicans to perform a mandatory safety modification. |
Quantity in Commerce |
93 units. |
Distribution |
Throughout the United States and to Denmark, England, China, Italy, Mexico, Israel, and Puerto Rico. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
|