SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of a
FDA device recall Z-2030-2012 · posted 2012-07-18 · Terminated
Recall details
- Recalling firm
- Sigma
- Reason for recall
- Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represent common clinical practices.
- Action taken
- Sigma sent an Urgent: Customer Safety Alert dated April 23, 2012 via UPS delivery to all consignees requesting both acknowledgement of notification and confirmation that recommended actions have been taken. Customers are asked to follow the instructions contained in the recall letter. Customers with questions may contact the firm at 800-356-3454 ext 300.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 2,048 CD's
- Distribution
- Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.
- Date initiated
- 2012-04-23
- Date posted
- 2012-07-18
- Date terminated
- 2018-07-05
- Location
- Medina, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY (K042121) | Sigma Intl. | 2004-08-26 |