Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog number 801046.
FDA device recall Z-0381-2007 · posted 2007-02-01 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- Following installation of software version 1.30 in October 2006, the firm confirmed a complaint that the new software caused a discrepancy in the pump speed calculation and caused the pump to stop during clinical use and a ''connect motor'' message to be displayed.
- Action taken
- Customers were notified by phone, fax, email or by a Terumo representative of these problems between 11/08/06 and 11/13/06 and instructed to not use the unit until new software had been installed. All version 1.30 software was replaced and version 1.40 installed prior to 12/4/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 35
- Distribution
- Nationwide.
- Date initiated
- 2006-11-08
- Date posted
- 2007-02-01
- Date terminated
- 2007-06-11
- 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 |