Z-0785-03

MAC-LAB 5000EX systems

Name: Z-0785-03 MAC-LAB 5000EX systems
Creator: General Electric Medical Systems Information Technology
Published: 2003-04-14
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies, Inc. / initiated 2003-04-14 / Terminated

FDA source

General Electric Medical Systems Information Technology began a recall of MAC-LAB 5000EX systems on 2003-04-14. The reason FDA records is "There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0785-03
Status: Terminated
Initiated: 2003-04-14
Posted: 2003-04-25
Terminated: 2004-06-24
Recalling firm: GE Medical Systems Information Technologies, Inc.
Product: MAC-LAB 5000EX systems
Product code: KMI Monitor, Bed Patient
Reason for recall: There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.
FDA 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.
Distribution: The recalled products were shipped to hospitals located nationwide in the United States and to other consignees located worldwide.
Product codes and lots: The affected systems have serial numbers with XC and 4A as 3rd and 4th characters in the serial number

Product code KMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)