—#85943

Product

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 product code: DXJ — Display, Cathode-Ray Tube, Medical
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K992636
Affected lot / code info: S/W Version D.02

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

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

Timeline

Recall initiated: 2009-10-21
Posted by FDA: 2009-11-24
Terminated: 2016-08-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85943. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.