—#68629

Product

IntelliVue Clinical Information Portfolio Critical Care Release D, Version D.00.00 Product Number: 865047. This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records 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: Version D.00.00

Why it was recalled

Medications prescribed for one patient were printed on the record of another patient.

Root cause (FDA determination)

Software design

Action the firm took

Philips Medical issued letter notification, dated 29 Feb 2008 to customers titled; "Urgent Medical Device Correction Notice". Customers were asked to not solely rely on the Worklist to remind them when to administer orders or interventions until the software has been upgraded. Customers should review the reminders and verify orders and interventions on the Medication Administration Record and Administration record. The correction will be in the form of a software upgrade and will be performed remotely by Philips service personnel.

Recalling firm

Firm: Philips Medical Systems
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Nationwide Canada, Australia, Austria, Belgium, Denmark., France, Finland, Germany, Great Britain, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, and UAE

Timeline

Recall initiated: 2008-03-04
Posted by FDA: 2008-08-23
Terminated: 2016-08-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #68629. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.