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Terminated

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

FDA Recall Z-1208-03 · Posted 2003-09-11

Recalling FirmHarvard Clinical Technology
Recall StatusTerminated
Product CodeFRN
Date Initiated2003-08-11
Date Terminated2012-05-07
Product Quantity384 units

Reason for Recall

Under specific sequence conditions, the unit may apper to be infusing, but is not

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952794HARVARD 2 SYRINGE PUMPHarvard Apparatus, Inc. · 1995-09-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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