Terumo Advanced Perfusion System 1; Integrated (Sarns) Centrifugal System Control Unit; Catalog number 801046.
FDA device recall Z-0492-2007 · posted 2007-02-14 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- The pump may lose communication with the central control monitor, causing the monitor to display a service message "System Computer Needs Service" and to become non-operational.
- Action taken
- Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 343
- Distribution
- Worldwide distribution --- including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China,
- Date initiated
- 2006-10-16
- Date posted
- 2007-02-14
- 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 |