Recall Z-1540-2008 ยท DXJ Display, Cathode-Ray Tube, Medical
Philips Medical Systems
CareVue Chart Release C ,Versions C.00.00 through C.00.06 Product No. 862246. 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.
| Date | Aug 23, 2008 (initiated Mar 4, 2008) |
| Status | Terminated |
| Reason | Medications prescribed for one patient were printed on the record of another patient. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 138 for products |
| Distribution | Nationwide Canada, Australia, Austria, Belgium, Denmark., France, Finland, Germany, Great Britain, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, and UAE |
| 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 |