Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA. Intende
FDA device recall Z-0824-2010 · posted 2010-03-04 · Terminated
Recall details
- Recalling firm
- Abiomed, Inc.
- Reason for recall
- Console shut down with no audible alarm
- Action taken
- Abiomed initiated the recall by telephone contact and followed with a Recall Letter dated January 27, 2010. Consignees were informed that a Field Service Engineer will be in contact and schedule a time to visit and correct the affected device. For further information, contact Abiomed Quality Assurance at 1-978-656-1543 or Abiomed Field Service at 1-800-554-8666.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DSQ
- Quantity affected
- 496 units
- Distribution
- Worldwide Distribution -- United States, Australia, Brazil, China, Hong Kong, Japan, Mexico and Germany.
- Date initiated
- 2009-12-16
- Date posted
- 2010-03-04
- Date terminated
- 2014-07-02
- Location
- Danvers, MA
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