—#95226

Product

Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Version D.00 through D.03.

FDA product code: DXJ — Display, Cathode-Ray Tube, Medical
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K992636
Affected lot / code info: Philips IntelliVue Clinical Information Portfolio Release D.XX, where XX is 00, 01, 02 or 03.

Why it was recalled

Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending interventions not being generated after the first 24 hours.

Root cause (FDA determination)

Software design

Action the firm took

Philips Healthcare issued an Urgent Medical Device Correction letter dated October 15, 2010 to customers. Customers are asked to follow the guidelines in the "Action to be taken by Customer/User" section of the Urgent Medical Device Correction Notice until they receive their software correction. The correction will be in the form of a software upgrade and will be performed by Philips service personnel. Contact 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: Worldwide Distribution: USA, including states of CA, DC, FL, IL, IN, KY, MA, MD, ME, NJ, NY, OK, RI, TX, VA, VT, and WV; and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KENYA, LATVIA, MALAYSIA, NETHERLANDS, NORWAY, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, and the UNITED KINGDOM.

Timeline

Recall initiated: 2010-10-19
Posted by FDA: 2010-11-18
Terminated: 2017-08-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95226. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.