Terumo Advanced Perfusion System 4 inch diameter Roller Pump; Model 801040.
FDA device recall Z-1266-06 · posted 2006-07-27 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- The pump may stop during the autodose delivery without completion of the dose delivery to the patient.
- Action taken
- Service technicians were notified on 9/30/05 to upgrade the software on these units by March 31, 2006 as follows: pump software to version 1.20, power manager software to version 1.20 and monitor software to version 2.2.1. U.S. software has all been upgraded and international upgrades are ongoing as of 7/7/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 1898 combined
- Distribution
- Nationwide, and worldwide, including Australia, Belgium, Canada, China, Dominican Republic, Egypt, Georgia, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore,
- Date initiated
- 2005-09-01
- Date posted
- 2006-07-27
- Date terminated
- 2008-06-11
- 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 |