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U.S. Department of Health and Human Services

Class 1 Device Recall Levitronix CentriMag

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  Class 1 Device Recall Levitronix CentriMag see related information
Date Initiated by Firm March 17, 2008
Date Posted July 23, 2008
Recall Status1 Terminated 3 on July 06, 2010
Recall Number Z-1902-2008
Recall Event ID 47409
510(K)Number K051209  
Product Classification extracorporeal blood circulation system. - Product Code KFM
Product Levitronix CentriMag Back-Up Console
Article Number: 201-30200; extracorporeal blood circulation system.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Levitronix, Llc
45 1st Ave
Waltham MA 02451-1105
Manufacturer Reason
for Recall		 Stops pumping: Interruption of CentriMag System support may occur when using a Valleylab Force FX-C Electrocautery Unit
FDA Determined
Cause 2		 Device Design
Action Levitronix issued an Urgent - Voluntary Device Correction letter on 3/17/08 mailed to the US distributor and requested to contact their accounts. The letter revises the warning in the CentriMag Console Manual. Levitronix is issuing revised manuals. On March 13, 2008 the firm emailed and mailed (FedEx) to the one Canadian Hospital and Health Canada was informed of the Voluntary Advisory Notice via email on Wednesday, March 19, 2008. Rest of the World: Wednesday, March 12, 2008 through Monday, March 17, 2008. The Notice was issued as a Voluntary Advisory Notice after review and follow up with the UK MHRA. On 7/24/08 the firm issued a revised Recall Letter to advise users not to use Valley Lab Force FX-C or SSE2L Electrosurgery device with the firm's CentriMag Blood Pumping System and include the significant risk to health. The firm revised their letter and Black Box Warning and reissued the letters to the hospital, surgeons, etc. on 7/24/08. On 2/5/09 the firm issued a "Follow-Up to Urgent Device Correction of 3/17/08 " to advise users of the software upgrade to be installed in the CentrigMag Primary software Version 3.0 and CentriMag Back Up console , software version 2.0. Site visits will be made by Levitronix between Feb 2009 and April 2009 , software upgrade installed and new Operating Manuals provided.
Quantity in Commerce 237 units
Distribution Worldwide Distribution: USA, Canada, Switzerland, UK, Italy, France, Greece, Spain, Slovenia, Czech, Turkey, South Africa, Argentina, Chile, Panama, Singapore, Taiwan, Israel, and Saudi Arabia.
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 = KFM and Original Applicant = LEVITRONIX LLC.
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