Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 8
FDA device recall Z-0930-2007 · posted 2007-06-30 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- System 1 power supply may electrically short to the main console, disrupting normal system operation by causing unexpected re-setting or shutdown of pumps and modules, false alarms and/or overheating and failure of the central control monitor.
- Action taken
- The firm corrected the complaint units at the time of the complaints in 2005. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that their system will be corrected when replacement components become available.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 416 for both models
- Distribution
- Worldwide: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan and Singapore.
- Date initiated
- 2005-02-01
- Date posted
- 2007-06-30
- Date terminated
- 2009-07-07
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH (K022947) | Terumo Cardiovascular Systems Corp. | 2003-03-20 |