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U.S. Department of Health and Human Services

Class 2 Device Recall Medrad 9500 Interface Cables

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  Class 2 Device Recall Medrad 9500 Interface Cables see related information
Date Initiated by Firm September 29, 2006
Date Posted December 15, 2006
Recall Status1 Terminated 3 on June 20, 2007
Recall Number Z-0258-2007
Recall Event ID 36596
510(K)Number K983250  &K954120  
Product Classification Interface Cables - Product Code MWI
Product Invasive Blood Pressure Interface Cables: a)
Medrad 9500 Multigas monitor for MRI, Invasive Blood Pressure Interface Cable (Part # 3006314) for use with Abbott/Hospira IBP Transducer b) Invasive Blood Pressure Interface Cable (Part # 3008772) for use with Braun IBP Transducers. The product is an accessory to patient physiological monitor.
Code Information Catalog number 3006314 and 3008772
Recalling Firm/
Manufacturer		 Medrad Inc
1 Medrad Dr
Indianola PA 15051-9759
For Additional Information Contact Kimberly Platt
412-767-2400
Manufacturer Reason
for Recall		 Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings.
FDA Determined
Cause 2		 Other
Action The recalling firm contacted all affected customers via telephone or letter dated November 20, 2006 to inform them of the problem and instruct them to return the cables or apply corrective labeling.
Quantity in Commerce 80 units
Distribution Worldwide distribution ---- including USA state of CA, CO, HI, IL, IN, MA, MD, NJ, NY, OH, PA, TX, and WA and countries of The Netherlands, Denmark, Australia, Brazil, Italy, and Japan.
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 = MWI and Original Applicant = MAGNETIC RESONANCE EQUIPMENT CORP.
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