Z-0768-2007

Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4...

Name: Z-0768-2007 Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4...
Creator: Smiths Medical MD, Inc.
Published: 2007-02-03
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-02-03 / Terminated / root cause: software

FDA source

Smiths Medical MD, Inc. began a recall of Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4. Medex, 4350 Green Parkway, Suite 200. Duluth, GA 30096 on 2007-02-03. The reason FDA records is "Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump's startup sequence when the pump's Preventative Maintenance Alarm goes off, preventing the pump...". 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-0768-2007
Status: Terminated
Initiated: 2007-02-03
Posted: 2007-04-26
Terminated: 2011-02-10
Recalling firm: Abbott Medical
Product: Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4. Medex, 4350 Green Parkway, Suite 200. Duluth, GA 30096
Product code: FRN Pump, Infusion
Reason for recall: Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump's startup sequence when the pump's Preventative Maintenance Alarm goes off, preventing the pump from completing its power up routine. Lock-up occurs and the pump will not function.
Root cause tag: software
FDA root cause: Other
Action: Consignees were initially notified of the recall via a Customer Information Bulletin which was sent via electronic mail 2/3/07 and confimed with a telephone conversation. A Product Recall Notification and a Product Recall Bulletin will be sent to all consignees via the mail on 2/16/07.
Quantity in commerce: 23,519
Distribution: Nationwide, Canada, and Italy.
Product codes and lots: Model 3500 pump with 4.1.4 or 4.1.3 software.

Product code FRN

K982640Class IIMedex 3000 Series Syringe Infusion PumpMedex, Inc. / cleared 1999-04-06

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)