IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. Intended for use in data collect
FDA device recall Z-0418-2010 · posted 2009-11-24 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- A software defect exists in the ICIP Release 0.02 scheduling function for order management such that if a user edits either the Schedule Time or the Stop Time for an existing order, the corresponding intervention(s) for the order may not be created.
- Action taken
- Philips Medical Systems notified accounts by letter on October 21, 2009, of the release ICIP version D.03, which contains a software correction . A Philips representative will schedule the implementation of this upgrade. Please contact the Philips Customer Care Center with questions or concerns about this correction at 1-800-722-9377.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DXJ
- Quantity affected
- 53 units
- Distribution
- MD, RI, WV, and TX Australia Belgium Denmark France Italy Malaysia Singapore Spain Switzerland Taiwan United Arab Emirates United Kingdom and Ireland
- Date initiated
- 2009-10-21
- Date posted
- 2009-11-24
- Date terminated
- 2016-08-22
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A (K992636) | Hewlett-Packard Co. | 1999-08-31 |