Recall Z-1541-2008
Philips Medical Systems · initiated March 4, 2008
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.
Codes / lots: Version D.00.00
Reason for recall
Medications prescribed for one patient were printed on the record of another patient.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-1541-2008
- Initiated
- March 4, 2008
- Posted by FDA
- August 23, 2008
- Terminated
- August 15, 2016
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- 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
- Recalling firm
- Philips Medical Systems, Andover, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1540-2008 | CareVue Chart Release C ,Versions C.00.00 through C.00.06 Product No. 862246. This…Medications prescribed for one patient were printed on the record of another patient. | 03/04/2008Terminated |