Recall Z-0418-2010 ยท DXJ Display, Cathode-Ray Tube, Medical
Philips Healthcare Inc.
IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage
| Date | Nov 24, 2009 (initiated Oct 21, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992636 | HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A Hewlett-Packard Co., Aug 31, 1999 |