Software Versions V1.2R,or earlier for the Harvard 2, Dual Infusion Pump (P/N 2002-001)
FDA device recall Z-1208-03 · posted 2003-09-11 · Terminated
Recall details
- Recalling firm
- Harvard Clinical Technology
- Reason for recall
- Under specific sequence conditions, the unit may apper to be infusing, but is not
- Action taken
- 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
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 384 units
- Distribution
- Nationwide
- Date initiated
- 2003-08-11
- Date posted
- 2003-09-11
- Date terminated
- 2012-05-07
- Location
- South Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HARVARD 2 SYRINGE PUMP (K952794) | Harvard Apparatus, Inc. | 1995-09-15 |