Class 2 Device Recall IntelliVue Clinical Information Portfolio

• Date Initiated by Firm: July 08, 2011
• Date Posted: August 31, 2011
• Recall Status: Terminated on August 13, 2020
• Recall Number: Z-3111-2011
• Recall Event ID: 59297
• 510(K)Number: K100272 K992636
• Product Classification: Display, cathode-ray tube, medical - Product Code DXJ
• Product: Philips Medical: 865047 IntelliVue Clinical Information Portfolio Release D.03 865209 IntelliVue Clinical Information Portfolio Release E.00 and E.01 865300 IntelliVue Clinical Information Portfolio NICU Link 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.
• Code Information: Software version: D.03, E.0, or E.01 of the software
• FEI Number: 1218950
• Recalling Firm/ Manufacturer: Philips Healthcare Inc.; 3000 Minuteman Road; Andover MA 01810
• For Additional Information Contact: SAME; 978-687-1501
• Manufacturer Reason for Recall: Under certain circumstances, edits to an order can result in unintended scheduled interventions on the IntelliVue Clinical Information Portfolio. A patient may receive interventions or additional medication doses that are not intended.
• FDA Determined Cause: Software design
• Action: Philips Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated July 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the 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. Philips has developed a software upgrade to address this problem in the short term. This upgrade will be available immediately. This software upgrade will be performed by Philips service personnel. While customers await the correction of their devices, customers are instructed to follow the instructions for use for the device, which includes the directions to: 1. Always use the medication administration record (MAR) in determining patient care. 2. Always review orders and pending administrations in the administration record after any changes to an order are stored. For the longer term, Philips is developing safeguards intended to minimize the potential for similar errors resulting from order changes and upgrade to be available in September 2011. If you need any further information or support concerning this issue, please contact your local Philips representative.
• Quantity in Commerce: 454 units
• Distribution: Worldwide Distribution-USA (nationwide) 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 UNITED KINGDOM.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DXJ; 510(K)s with Product Code = DXJ