FDA Medical Device Recalls (openFDA)
Spacelabs Medical Incorporated: BirthNet OB Data Management System 91861
- Recall number
- Z-0115-06
- Recalling firm
- Spacelabs Medical Incorporated
- Product
- BirthNet OB Data Management System 91861
- Status
- Terminated
- Initiated
- 2005-10-13
- Posted
- 2005-11-01
- Terminated
- 2011-01-17
- Reason
- Potential for incorrect weight to be displayed.
- Root cause
- Other
- Action
- On 10/13/04 the firm sent letters to customers advising of the error, and that software to correct the problem will be released the end of October. Service personnel will install new software.
- Quantity
- 44 devices
- Distribution
- Distribution was to 44 medical facilities/hospitals nationwide.
- Lot, serial or model codes
- All serial numbers involved
- 510(k) numbers
- ["K965008"]
- PMA numbers
- not on file
- Product code
- HGM
- Firm FEI
- 3010157426
- Firm city
- Issaquah
- Firm state
- WA
- 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