CareVue Chart Release C ,Versions C.00.00 through C.00.06 Product No. 862246. This device is a clinical information syst
FDA device recall Z-1540-2008 · posted 2008-08-23 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Medications prescribed for one patient were printed on the record of another patient.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DXJ
- Quantity affected
- 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
- Date initiated
- 2008-03-04
- Date posted
- 2008-08-23
- Date terminated
- 2016-08-15
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A (K992636) | Hewlett-Packard Co. | 1999-08-31 |