Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model
FDA device recall Z-0311-2007 · posted 2006-12-27 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- The battery status light on the front panel may not accurately reflect the actual status of the battery. The battery may contain more charge than indicated.
- Action taken
- U.S. consignees were visited and new software installed between May 2004 and November 2005. Currently, approximately 50% of exported units have been upgraded.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 159
- Distribution
- Worldwide, including USA, Belgium, Canada, China, Egypt, Germany, India, Indonesia, Japan, Malaysia, Pakistan, Republic of China, Singapore, South Africa, South Korea and United Arab Emirates.
- Date initiated
- 2004-05-01
- Date posted
- 2006-12-27
- Date terminated
- 2007-02-01
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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 |