Z-0891-2007

GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. , GE Medical...

Name: Z-0891-2007 GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. , GE Medical...
Creator: General Electric Medical Systems Information Technology
Published: 2007-01-24
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies, Inc. / initiated 2007-01-24 / Terminated / root cause: software

FDA source

General Electric Medical Systems Information Technology began a recall of GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. , GE Medical Systems Information Technologies, Inc., 8200 W. Tower... on 2007-01-24. The reason FDA records is "Alarm and Reboot problems: Two separate issues could occur with the CIC Pro system when used with Telemetry. Each issue occurs in software version v4.1 only; A) the system may experience a loss of audible alarms when...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0891-2007
Status: Terminated
Initiated: 2007-01-24
Posted: 2007-06-06
Terminated: 2011-12-10
Recalling firm: GE Medical Systems Information Technologies, Inc.
Product: GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. , GE Medical Systems Information Technologies, Inc., 8200 W. Tower Ave. Milwaukee, Wisconsin USA. (System hardware consists of a processing unit and a monitor)
Product code: DSI Detector And Alarm, Arrhythmia
Reason for recall: Alarm and Reboot problems: Two separate issues could occur with the CIC Pro system when used with Telemetry. Each issue occurs in software version v4.1 only; A) the system may experience a loss of audible alarms when operating system memory resources reach 170MB and/or B) the system may intentionally or unexpectedly reboot .
Root cause tag: software
FDA root cause: Other
Action: GE Healthcare sent a certified letter titled "Urgent Medical Device Correction" to customers on 3/13/07 that explained the short and long term solutions and that the company would be providing a software update that will rectify the issue specific to CIC Pro v4.1 software.
Quantity in commerce: 5,190 Units
Distribution: Nationwide
Product codes and lots: All serial numbers of Software Version 4.1

Product code DSI

K032370Class IICic Pro Clinical Information Center Central StationGe Medical Systems Information Technologies / cleared 2003-08-13

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)