FDA Medical Device Recalls (openFDA)
Harvard Clinical Technology: Software Versions V1.2R,or earlier for the Harvard 2, Dual Infusion Pump (P/N 2002-001)
- Recall number
- Z-1208-03
- Recalling firm
- Harvard Clinical Technology
- Product
- Software Versions V1.2R,or earlier for the Harvard 2, Dual Infusion Pump (P/N 2002-001)
- Status
- Terminated
- Initiated
- 2003-08-11
- Posted
- 2003-09-11
- Terminated
- 2012-05-07
- Reason
- Under specific sequence conditions, the unit may apper to be infusing, but is not
- 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
- 384 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Software versions V1.2R or earlier
- 510(k) numbers
- ["K952794"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1218257
- Firm city
- South Natick
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28