FDA Recall Terminated

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.

Recall: Z-0418-2010 · Initiated October 21, 2009

Recall

Recall Number
Z-0418-2010
Event Number
53593
Firm
Philips Healthcare Inc.
FEI Number
1218950
Product Code
DXJ
Status
Terminated
Root Cause
Software design
Initiated
October 21, 2009
Posted
November 24, 2009
Terminated
August 22, 2016
Address
3000 Minuteman Road, Andover, MA, 01810

Description

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.

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.

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.

Distribution

MD, RI, WV, and TX Australia Belgium Denmark France Italy Malaysia Singapore Spain Switzerland Taiwan United Arab Emirates United Kingdom and Ireland

Quantity

53 units