CareVue Chart Release C.O Part Number: 862246 Intended for use in data collection, storage, and management with independ
FDA device recall Z-1436-2009 · posted 2009-05-27 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DXJ
- Quantity affected
- 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 Ara
- Date initiated
- 2009-05-05
- Date posted
- 2009-05-27
- Date terminated
- 2012-03-06
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A (K992636) | Hewlett-Packard Co. | 1999-08-31 |