—#81825

Product

CareVue Chart Release C.O Part Number: 862246 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: Serial Numbers: 4621A00101, 4621A00102, 4621A00103, 4621A00104, 4621A00105, 4621A00106, 4621A00107, 4621A00108, 4621A00109, 4621A00110, 4621A00111, 4621A00112, 4621A00113, 4621A00114, 4621A00115, 4621A00116, 4621A00117, 4621A00118, 4621A00119, 4621A00120, 4621A00121, 4621A00122, 4621A00123, 4621A00124, 4621A00125, 4621A00126, 4621A00127, 4621A00128, 4621A00129, 4621A00130, 4621A00131, 4621A00132, 4621A00133, 4621A00134, 4621A00135, 4621A00136, 4621A00137, 4621A00138, 4621A00139, 4621A00140, 4621A00141, 4621A00142, 4621A00143, 4621A00144, 4621A00145, 4621A00146, 4621A00147, 4621A00148, 4621A00149, 4621A00150, 4621A00151, 4621A00152, 4621A00153, 4621A00154, 4621A00155, 4621A00156, 4621A00157, 4621A00158, 4621A00159, 4621A00160, 4621A00161, 4621A00162, 4621A00163, 4621A00164, 4621A00165, 4621A00166, 4621A00167, 4621A00168, 4621A00169, 4621A00170, 4621A00171, 4621A00172, 4621A00193, 4621A00194, 4621A00195, 4621A00196, 4621A00197, 4621A00198, 4621A00199, 4621A00200, 4621A00201, 4621A00202, 4621A00203, 4621A00204, 4621A00205, 4621A00206, 4621A00207, 4621A00208, 4621A00209, 4621A00210, 4621A00211, 4621A00213, 4621A00214, 4621A00217, 4621A00218, 4621A00219, 4621A00220, 4621A00221, 4621A00222, 4621A00223, and 4621A00224.

Why it was recalled

Software: A software defect under certain circumstances could lead to the unintended administration of a duplicate dose of a scheduled medication within a single 24 hour period

Root cause (FDA determination)

Software design

Action the firm took

Philips Medical notified accounts by letter on 5/6/09 the Urgent - Medical Device Correction notification. While customers await the correction of their devices, customers are given the following instructions: Clinicians should not rely solely on the worklist within CareVue Chart to determine actionable orders for the patient until their software is upgraded. Clinical users should always use the medication administration record (MAR) and the administration record in determining the care their patients receive in addition to the critical care worklist. Philips is currently developing a correction that will be available at no additional charge. A Philips representative will notify customers when the software correction becomes available. If further assistance is needed, customers are to contact the Philips Customer Care Center 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, FL, MA, OH, OK, RI, VT, and WV and countries of Canada, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and the United Kingdom.

Timeline

Recall initiated: 2009-05-05
Posted by FDA: 2009-05-27
Terminated: 2012-03-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81825. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.