—#102145

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.

FDA product code: DXJ — Display, Cathode-Ray Tube, Medical
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K100272, K992636
Affected lot / code info: Software version: D.03, E.0, or E.01 of the software

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-07-08
Posted by FDA: 2011-08-31
Terminated: 2020-08-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #102145. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.