Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764
FDA device recall Z-0315-2007 · posted 2006-12-27 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.
- Action taken
- U.S. consignees were visited and corrections made between May 2004 and November 2005. Foreign affiliates were instructed to make corrections on international units, but the firm has not received confirmation yet that these units have been corrected.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 5
- Distribution
- Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.
- Date initiated
- 2004-05-01
- Date posted
- 2006-12-27
- Date terminated
- 2009-07-14
- 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 |