FDA Medical Device Recalls (openFDA)
GE Medical Systems Information Technologies: GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is
- Recall number
- Z-1291-03
- Recalling firm
- GE Medical Systems Information Technologies
- Product
- GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is
- Status
- Terminated
- Initiated
- 2003-05-21
- Posted
- 2003-09-23
- Terminated
- 2003-10-27
- Reason
- The 2120 Main Board on device lacks required external safety 'watchdog' circuit.
- Root cause
- Other
- Action
- The firm mailed or faxed a recall letter to consignees on May 14, 2003 followed by a phone call to each account within two weeks to arrange for a service technician visit to correct the monitors. The recall letter warned the hospitals of the problem and a work around.
- Quantity
- 170
- Distribution
- The monitors were distributed to 8 hospitals in SC, WI, CA, MN, TX, MD and NV, as well as two hospitals in France.
- Lot, serial or model codes
- All serial numbers are involved.
- 510(k) numbers
- ["K021135"]
- PMA numbers
- not on file
- Product code
- HGM
- Firm FEI
- 1030184
- Firm city
- Tampa
- Firm state
- FL
- 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