FDA Medical Device Recalls (openFDA)
General Electric Medical Systems Information Technology: MAC-LAB 5000EX systems
- Recall number
- Z-0785-03
- Recalling firm
- General Electric Medical Systems Information Technology
- Product
- MAC-LAB 5000EX systems
- Status
- Terminated
- Initiated
- 2003-04-14
- Posted
- 2003-04-25
- Terminated
- 2004-06-24
- Reason
- There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.
- Root cause
- Other
- Action
- A letter was sent to the consignees on April 14, 2003 and requested that the consignees correct the device or contact the firm to have them perform the correction.
- Quantity
- not on file
- Distribution
- The recalled products were shipped to hospitals located nationwide in the United States and to other consignees located worldwide.
- Lot, serial or model codes
- The affected systems have serial numbers with XC and 4A as 3rd and 4th characters in the serial number
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KMI
- Firm FEI
- 2124823
- Firm city
- Milwaukee
- 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