Recall Z-1436-2009 ยท DXJ Display, Cathode-Ray Tube, Medical
Philips Healthcare Inc.
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.
| Date | May 27, 2009 (initiated May 5, 2009) |
| Status | Terminated |
| Reason | 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 | Software design |
| Action | 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 correct |
| Quantity | 103 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992636 | HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A Hewlett-Packard Co., Aug 31, 1999 |