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.
This recall has been terminated (originally issued November 24, 2009).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- October 21, 2009
- Posted
- November 24, 2009
- Terminated
- August 22, 2016
- Recall Number
- Z-0418-2010
- Quantity
- 53 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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.
Distribution
MD, RI, WV, and TX Australia Belgium Denmark France Italy Malaysia Singapore Spain Switzerland Taiwan United Arab Emirates United Kingdom and Ireland
Lot / Code Info
S/W Version D.02
Root Cause
Software design
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.