FDA Medical Device Recalls (openFDA)
Gambro BCT, Inc.: Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
- Recall number
- Z-0078-2008
- Recalling firm
- Gambro BCT, Inc.
- Product
- Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
- Status
- Terminated
- Initiated
- 2007-09-18
- Posted
- 2007-10-31
- Terminated
- 2008-01-25
- Reason
- Under specific conditions, apheresis machine could return up to 60mL of air to the patient.
- Root cause
- Software design
- Action
- All consignees were notified by telephone beginning 09/17/2007. They were given instructions on how to safely use the machine. Letters were also sent on 09/22/2007 restating the information.
- Quantity
- 15 units
- Distribution
- US, Canada, Australia, Europe.
- Lot, serial or model codes
- Part No. 61000, Serial Numbers 1P00100 to 1P00141.
- 510(k) numbers
- ["K071079"]
- PMA numbers
- not on file
- Product code
- LKN
- Firm FEI
- 1000117351
- Firm city
- Lakewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28