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.
FDA Recall Z-0418-2010 · Posted 2009-11-24
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Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeDXJ
Date Initiated2009-10-21
Date Terminated2016-08-22
Product Quantity53 units
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
MD, RI, WV, and TX Australia Belgium Denmark France Italy Malaysia Singapore Spain Switzerland Taiwan United Arab Emirates United Kingdom and Ireland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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