Z-1208-03

Software Versions V1.2R,or earlier for the Harvard 2, Dual Infusion Pump (P/N 2002-001)

Name: Z-1208-03 Software Versions V1.2R,or earlier for the Harvard 2, Dual Infusion Pump (P/N 2002-001)
Creator: Harvard Clinical Technology
Published: 2003-08-11
License: https://open.fda.gov/license/

Harvard Clinical Technology / initiated 2003-08-11 / Terminated

FDA source

Harvard Clinical Technology began a recall of Software Versions V1.2R,or earlier for the Harvard 2, Dual Infusion Pump (P/N 2002-001) on 2003-08-11. The reason FDA records is "Under specific sequence conditions, the unit may apper to be infusing, but is not". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1208-03
Status: Terminated
Initiated: 2003-08-11
Posted: 2003-09-11
Terminated: 2012-05-07
Recalling firm: Harvard Clinical Technology
Product: Software Versions V1.2R,or earlier for the Harvard 2, Dual Infusion Pump (P/N 2002-001)
Product code: FRN Pump, Infusion
Reason for recall: Under specific sequence conditions, the unit may apper to be infusing, but is not
FDA root cause: Other
Action: Harvard Medical Technology inc. notified customers by letter on 8/11/03, advising users of the software upgrade to version V1.3T. Facilities will be visited by technicians who will upgrade the software.
Quantity in commerce: 384 units
Distribution: Nationwide
Product codes and lots: Software versions V1.2R or earlier

Product code FRN

K952794Class IIHarvard 2 Syringe PumpHarvard Apparatus, Inc. / cleared 1995-09-15

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)