Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 8
FDA device recall Z-0433-2007 · posted 2007-02-14 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- A 'battery needs service' message may be displayed, or the remaining battery time may incorrectly become zero, even when the battery is fully functional.
- Action taken
- Consignees were sent a letter dated 11/10/06 informing them of the nature of the issues and that the firm would contact them to schedule a service call to install the software upgrade package. The software upgrade installation began at customers on 10/16/06, prior to issuance of the letter to consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 207
- Distribution
- Worldwide distribution ---- including USA and countries Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, S
- Date initiated
- 2006-10-16
- Date posted
- 2007-02-14
- Date terminated
- 2009-07-07
- Location
- Ann Arbor, MI
Monitor recalls programmatically
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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 |