Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical
FDA device recall Z-1090-2007 · posted 2007-07-23 · Terminated
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 24 units
- Distribution
- 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.
- Date initiated
- 2007-06-04
- Date posted
- 2007-07-23
- Date terminated
- 2008-03-02
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERFORMER CBP SYSTEM (K070213) | Rand S.R.L. | 2007-03-21 |
| MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB (K052555) | Rand S.R.L. | 2006-03-15 |