FDA Medical Device Recalls (openFDA)
General Electric Med Systems LLC: LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935
- Recall number
- Z-0387-06
- Recalling firm
- General Electric Med Systems LLC
- Product
- LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935
- Status
- Terminated
- Initiated
- 2004-09-02
- Posted
- 2006-01-11
- Terminated
- 2007-01-05
- Reason
- The Estimated Fetal Weight (EFW) result will be incorrect if the operator fails to perform the 'end exam' or new patient registration step before starting an EFW measurement procedure on the next patient.
- Root cause
- Other
- Action
- Devices will have software upgrades done by GE Field Service Technicians. The upgrade will include a dialog box which will display on the screen when prior data exists and a new patient is being registered.
- Quantity
- 2698
- Distribution
- nationwide and worldwide
- Lot, serial or model codes
- all serial numbers
- 510(k) numbers
- ["K014206"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- 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