Recalls / —
—#53035
Product
Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Manufactured by: RanD S.r.l 41036 Mendolla (MO) Italy. Distributed exclusively by Medtronic, Inc.
- FDA product code
- DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K052555, K070213
- Affected lot / code info
- Model Number: R5100052-Serial Numbers: 115, 118, 124, 138, 140, 141, 148, 113, 116, 117, 122,127, 130, 137 103, 109, 132, 135, 105, 107, 108, 110, 131, 133.
Why it was recalled
Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))
Root cause (FDA determination)
Other
Action the firm took
There are two separate letters dated June 4, 2007 for the customers, based on the configuration of the unit being inspected/updated in the field. These letters explains the situaiton and informs the customers that Medtronic will be visiting each customer site to inspect/update the units. Medtronic Service Technicians will complete a Field Action Certicate acknowledging the successful completion of the update.
Recalling firm
- Firm
- Medtronic Perfusion Systems
- Address
- 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088
Distribution
- Distribution pattern
- Worldwide Distribution: USA including states of PA, ND, MN, CA, AL, CO, MI, NY, AZ, and OH and countries of Sweden, Iceland, Latvia, Germany, Italy, Austria, Belgium, and France.
Timeline
- Recall initiated
- 2007-06-04
- Posted by FDA
- 2007-07-23
- Terminated
- 2008-03-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #53035. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.